FDA Report On Drug Shortages: Root Causes & Potential Solutions - National Pharmacy ...
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Member-Publication of the National Pharmacy Purchasing Association (NPPA)
Volume XXVI Issue 8, November 2019 Published by NPPA/Summerdale Enterprises, Inc.
FDA Report On Drug Shortages: The report identifies 3 root causes
Root Causes & Potential Solutions for drug shortages, as follows:
1) Lack of incentives for manu-
On October 29, the FDA announced the release of their new report, facturers to produce less prof-
titled: “Drug Shortages: Root Causes & Potential Solutions,” which itable medications;
examines the underlying factors responsible for drug shortages and 2) The market does not recognize
recommends enduring solutions. and reward manufacturers for
The inter-agency Drug Shortage Task Force, which was led by the “mature quality systems” that
FDA, oversaw the analysis of drug shortage data and development of focus on continuous improve-
recommendations in response to a request from 31 U.S. senators and ment and early detection of any
104 U.S. congressional representatives in June 2018. The report supply chain issues;
relies on information from stakeholders, published research, and 3) Logistical and regulatory chal-
economic analysis of market conditions affecting drug shortages. lenges that make it difficult
for the market to recover from
a disruption.
In addition, the report also
2020 CPhT Practice Exam recommends enduring solutions to
address drug shortages. These
On October 28, the Pharmacy Technician Certification Board solutions include the following:
(PTCB) of Washington, D.C. announced the availability of a Creating a shared understanding
new official practice exam for the 2020 Pharmacy Technician of the impact of drug shortages
Certification Exam® (PTCE®), in order to become a Certified on patients and the contracting
Pharmacy Technician (CPhT). practices that may contribute
The practice version is built to the same content specifications as to shortages;
the updated PTCE that launches in January 2020. Developing a rating system to
Unlike practice exams from other providers, the official practice incentivize drug manufacturers
exam has the same look, feel, and functionality as the actual PTCE. to invest in quality management
This allows candidates to become familiar with the real exam maturity for their facilities;
experience before test day. Don’t be scared, be prepared! Promoting sustainable private
The PTCE practice exam is available from Pearson Education Inc. sector contracts (e.g., with pay-
Fees are $29 each for individual purchases; or for employers and ers, purchasers, and group pur-
educators, discounted rates are offered when purchasing in bulk. chasing organizations), to make
To learn more and purchase, visit the Pearson Education website: sure there is a reliable supply of
https://home.pearsonvue.com/ptcb/practicetests medically important drugs.
In addition, the report describes
legislative proposals in the Presi-
dent’s Fiscal Year 2020 Budget
and planned FDA initiatives to
Highlights Inside This Edition prevent and mitigate shortages that
Biosimilar Drug Approvals Pages 14-16 look at the following: improved
Discontinued Drugs Pages 12-14 data sharing, risk management,
First Test to Detect HIV-1 Pages 66-67 lengthened drug expiration dates,
Flu Vaccine Products & News Pages 28-30
Tips for Healthier Holidays Pages 35-40 Continued on Page 73
Dexmedetomidine Fresenius Kabi provides the first-to-market generic RTU
bottle of Dexmedetomidine Hydrochloride in 0.9%
Hydrochloride in 0.9% Sodium Chloride Injection available in 20 mL vial,
50 mL bottle, and 100 mL bottle.
Sodium Chloride Injection • Available as Ready-to-Use
• No admixing required
First-to-market generic Ready-to-Use • May help reduce potential medication
(RTU) bottle to the Brand Precedex .
TM
preparation errors
• Can be used in dispensing machines
• Different sizes for various clinical needs
We leverage our 100-year history so that clinicians
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That’s How Fresenius Kabi Brings
Confidence Within Reach.
To place an order, contact your Sales Representative
or Customer Service at:
1.888.386.1300 | www.fresenius-kabi.com/usPharmacy Purchasing Outlook - November 2019 Page 3
Join Us For August 2020 Within This Edition
24th NPPA Conference! SUBJECT PAGE
Ad Rates & Info .............................. 74
Be sure to mark your calendars for our 24th Annual NPPA Advertisers:
Conference, returning to Bally’s Las Vegas August 11-13, 2020.
Accord Pharmaceuticals ................ 37
Dates: Tuesday August 11 through Thursday August 13
American Health Packaging .......... 11
Optional Pre-Conference 340B University, Monday August 10
Baxter Healthcare Corporation ...... 38-39
Registration for Attendees to open in January 2020! Look for Baxter Healthcare Corporation ...... 61
updates by email and on our NPPA website’s Home Page on the
Beutlich Pharmaceuticals .............. 27
right, under “NPPA Conference News.”
Also note that Apexus will be returning again to host an Broughton Pharmaceuticals .......... 29
optional 340B University event, on Monday August 10, which is Dr. Reddy’s Laboratories .............. 7
the day before our NPPA Conference begins. Registration usually Fresenius Kabi USA ...................... 2, 5
opens in April or May (check our website for updates).
Fresenius Kabi USA ...................... 49
Bally’s hotel room rates for our 2020 NPPA Group Room Block
Nexus Pharmaceuticals ................. 69
are being held at $89/night+tax, which has not increased for the past
2 years (plus mandatory Resort Fee of $35/night+tax). Par Pharmaceuticals ..................... 22-23
Pharmaceutical Associates ............ 19
Precision Dose .............................. 45
Pharmacy Purchasing Outlook (ISSN: 1094-9747)
Member-publication of NPPA (National Pharmacy Purchasing Association) Reliance Wholesale, Inc. ............... 76
Issued 10 times per calendar year (monthly except February and August) Sagent Pharmaceuticals ................. 15, 65
Published by: Summerdale Enterprises, Inc., dba NPPA
VistaPharm ................................... 33, 75
SEND ORDERS & CONTACT US AT: X-Gen Pharmaceuticals ................. 57
NPPA (National Pharmacy Purchasing Assocation)
Biosimilar Drug Approvals ............. 14-16
4747 Morena Blvd., Suite 340, San Diego, CA 92117-3468
858-581-6373, or 888-544-NPPA (toll-free) CPhT Practice Exam (2020) .......... 1
Fax: 858-581-6372. Website: www.PharmacyPurchasing.com
Diabetes Testing & Updates ........... 51-55
Staff of NPPA/Summerdale Enterprises Inc. Discontinued Drugs ......................... 12-14
Dale J. Kroll: President & CEO, Editor-In-Chief
Editorial .......................................... 4
Francine Morgano: Vice President, Event/Marketing Director & Editor
Jonathan Hewlett: Office & Advertising Manager, Lead Event Assistant FDA Report on Drug Shortages ...... 1, 73
Amy Empson: Office & Event Assistant First Test to Detect HIV-1 ............. 66-67
Leah Noble: Editorial Assistant & Website Manager
Flu Vaccine Products & News ........ 28-30
Pamela Herold: Editorial Assistant/Researcher & Event Assistant
Generic Approvals ......................... 6-10
NPPA Membership Rates: $125, 1-year; $216, 2-years (comes with 10 editions/year of
Pharmacy Purchasing Outlook, the member-publication of NPPA). Associate Memberships Government Agency News ............. 55-66
($69/year) are available when a Full Member exists at same facility/address (sharing the
publication of the Full Member). Issues are distributed via First Class U.S. Mail, by the end HAI & Antibiotic Resistance ........... 41-43
of the first week of the month after the publication issue month. See details on our website. Innovative Health News ................. 43-50
Disclaimer: Although articles are checked for accuracy as much as possible before
New Drugs/Indications ................... 16-28
being published, NPPA/Summerdale Enterprises, Inc. makes no representations or warranties
of any kind, express or implied, about the accuracy, completeness, suitability, or reliability News Briefs ..................................... 30-35
of any information presented in PPO or on its website. NPPA/Summerdale advises all
members reading content here to contact the stated primary source before acting upon any of NPPA Member-Related News
the information provided. Editorials and articles with bylines are the opinions and the
Renewing NPPA Members ............ 72
expressions solely of the writer, and not those of NPPA/Summerdale. Advertisements are
placed within their member-publication as provided by the advertising company or its Website Resources ........................ 73-74
authorized agent. The contents and claims presented in any ad represent those of the
advertising company, and not NPPA/Summerdale. NPPA/Summerdale will not be liable for Tips for Healthier Holidays ............. 35-40
any false, inaccurate, inappropriate, or incomplete information presented on the website, U.S. Trivia ...................................... 67-72
nor for any consequences arising from the use of any information that is or has been in their
member-publication or on its website. .
Copyright 2019 by Summerdale Enterprises, Inc., dba NPPA. Materials may not be reproduced without
written permission of NPPA, except for short reviews with attribution. Page 74 may be copied.Page 4 Pharmacy Purchasing Outlook - November 2019
Eventually he even created differ- abundance of orders that are re-
Editorial ent job descriptions for me, in or- ceived daily in the pharmacy.
By Pamela Herold, CPhT der to make the best use of my Processes have changed with the
NPPA Editorial Assistant skill sets. He has truly been my advancement of automation en-
greatest supporter, even when abling the pharmacy to move in a
Thankful others doubted me, and played a more efficient streamline manner
Our lives are incredibly busy, and key role in helping me get to and keeping the pharmacy opera-
as a result, we sometimes do not where I am today. tional. The accuracy of the au-
take time to stop and reflect on the In the pharmacy setting, there are tomation has taken a lot of the
positive things that have enhanced many things to be thankful for as medication errors out of play,
our lives over the years. However, well, such as helping patients in which is good for our patients
with the holidays and end of the need of better health. Medicine and their safety.
year approaching, this is naturally a has advanced by leaps and bounds, People are a valuable asset and
time of year in which people stop to and without these healing tools, I am appreciative of all my past
count their blessings. we would not be able to help our pharmacy co-workers. Over the
If not for influential people in my patients. We work in a great in- years, I have experienced many
life, I believe my knowledge base dustry which impacts nearly every times where a technician caught
and quality of life would be signifi- American at some point in their an error before it ever reached the
cantly less than it is. Thus, I would lives, and it’s a privilege to be able patient; and have seen where they
like to share a few things I am to be a part of it and help others. go out of their way to do what-
thankful for. Being blessed with good health ever needs to be done to get
We have all seen winners on at this stage in my life, I was espe- medication up to a patient’s
award shows stand up and say: “I cially thankful to be on the giving room. The teamwork was not
would like to thank my Mom and side of the pharmacy. Everyone’s always perfect, but overall our
Dad.” Well, I have to agree, I am part in the pharmacy is important pharmacy staff worked together
very thankful for both my parents. and although I did not have direct for the sake of the patient, which
Although not perfect, they instilled patient contact, I would like to is our ultimate goal.
in me good morals, values, and think my job contributed to help- Is there a person or persons that
shared many aspects of their life ing our patients remain safe during have made a difference in your
that contributed to how I think and their hospital stay. life that you are thankful for?
who I am as a person today. As I I am also grateful for how tech- Whether it was a relative, friend,
perform certain tasks, memories nology has improved pharmacy or neighbor who planted a posi-
come to mind and I am blown away automation and how it has ad- tive seed in our life, this may be
at the little seed that was planted vanced the way we process a good time to thank them, even
years ago and how it has blossomed medication orders and the medi- if it’s just in your own mind and
into a good habit or method of how cations themselves. There are so not out loud.
I manage through situations. many different drugs with nu-
Another significant positive con- merous strengths, we would be
tributor to my life was the hospital hard pressed to keep up with the
Pharmacy Director at my previous
job. He is an incredibly forward
thinker who can see outside the box NPPA Mission
and even beyond the bigger picture
where most people would never The Mission of NPPA is to:
even think about, and his vision Promote the Profession of Pharmacy Purchasing.
and work ethics are the highest Provide Specific and Enhanced Educational Opportunities for
quality you will ever find. When the Pharmacy Buyer.
he hired me about 15 years ago, Provide a Unified Voice for the Professional Pharmacy Buyer.
he took a chance on me not having Affirm Pharmacy Purchasing as a unique and important
specific experience, and gave me specialty within the Pharmacy Profession.
the opportunity to learn many Affirm that Pharmacy Purchasing is an important aspect of
areas of the pharmacy and obtain Total Patient Care.
my pharmacy tech certification.The Leader
for a Reason
For additional information,
contact your Sales Representative
Known. Trusted. Reliable. or visit www.diprivan-us.com
www.fresenius-kabi.com/us
1.888.386.1300
Full prescribing information can be found at www.fresenius-kabi.com/us.Page 6 Pharmacy Purchasing Outlook - November 2019
Generic Approvals & News Cisatracurium Besylate PF Injection -
Zydus Pharmaceuticals
On November 5, Zydus Pharmaceuti-
Adapalene/Benzoyl Peroxide Gel - cals, Inc. of Pennington, New Jersey an-
Glenmark Pharmaceuticals nounced they received final FDA ap-
On November 11, Glenmark Pharmaceuticals, Inc. USA of proval to market Cisatracurium Besylate
Mahwah, New Jersey announced they received final FDA preservative-free (PF) Single-Dose Vials
approval for Adapalene/Benzoyl Peroxide Gel 0.1% and 2.5%. for Injection, in the following strengths:
This product compares to Epiduo® Gel 0.1% and 2.5% 10mg/5mL (2mg/mL);
by Galderma Laboratories L.P. It is indicated to treat acne 200mg/20mL (10mg/mL).
vulgaris (severe acne) in people who are at least 9 years old. Cisatracurium Besylate compares to
Recent annual U.S. sales of both the brand and its generic Nimbex Injection by AbbVie Inc. It is
equivalents (ending September 2019) were $33.7 million, indicated before general anesthesia in
according to IQVIA™. preparation for surgery, as it helps keep
the body still during surgery and also
Bretylium Tosylate Injection Launch - relaxes the throat so a breathing tube can
ANI Pharmaceuticals be more easily inserted.
On October 31, ANI Pharmaceuticals, Inc. of Baudette, This product will be manufactured by
Minnesota and its partner Pharmaceutics International Inc. of Liva Pharmaceuticals Ltd., a wholly-
Hunt Valley, Maryland jointly announced they have received owned subsidiary company of Zydus
FDA approval of a Prior Approval Supplement for Bretylium Cadila Healthcare Ltd.
Tosylate Injection 500mg/10mL (50mg/mL).
This currently unavailable drug is expected to launch by the Clobetasol Propionate Solution -
end of the year, in December (2019). ANI will be distributing Alembic Pharmaceuticals
the product, and Pharmaceutics is its exclusive manufacturer. On October 22, Alembic Pharmaceuti-
First introduced in 1986, Bretylium Tosylate Injection was cals Ltd. of Gujurat, India (with U.S. in-
added to the Advanced Care Life Support (ACLS) guidelines corporated headquarters in Bridgewater,
and algorithms recommended by the American Heart Associa- New Jersey) announced that its joint ven-
tion (AHA) in the 1990’s. Due to raw material shortages, the ture company Aleor Dermaceuticals Ltd.
drug has not been available in the United States since 1999. (also of Gujurat, India) has received final
Prior to its discontinuation, Bretylium Tosylate was com- FDA approval for its Abbreviated New
monly stocked as a standard drug on crash carts. ANI estimates Drug Application (ANDA) of Clobetasol
that there are approximately 180,000 crash carts in the U.S. and Propionate Topical Solution 0.05%.
will recommend at least 2 vials of Bretylium Tosylate per crash This product compares to Temovate®
cart. Use of Bretylium Tosylate Injection should be limited to Topical Solution 0.05% by Fougera Phar-
intensive care units, coronary care units, or other facilities maceuticals Inc. It is indicated for short-
where equipment and personnel for constant monitoring of term topical treatment of inflammatory
cardiac arrhythmias and blood pressure are available. and pruritic manifestations of moderate to
Bretylium Tosylate Injection is indicated in the prophylaxis severe corticosteroid-responsive der-
and therapy of ventricular fibrillation. It is also indicated for the matoses of the scalp.
treatment of life-threatening ventricular arrhythmias, such as Clobetasol Propionate Topical Solution
ventricular tachycardia that have failed to respond to adequate 0.05% had 2018 U.S. sales of $33 million,
dose of a first-line antiarrhythmic agent, such as lidocaine. according to IQVIA.
Arthur S. Przybyl, ANI’s President & CEO, commented:
“We are excited to introduce this important life-saving cardiac Desonide Ointment 0.05% -
drug and provide physicians with another valuable tool to treat Alembic Pharmaceuticals
patients with ventricular arrhythmias. ANI will be supporting On October 24, Alembic Pharmaceuti-
the launch of this drug with a broad awareness campaign to cals Ltd. of Gujurat, India (with U.S. in-
educate healthcare professionals on the availability, uses, and corporated headquarters in Bridgewater,
utility of this important drug.” New Jersey) announced that its joint
Continued on Page 8I N J E C TA B L E S
You make Promises. We help you keep them.
Your customers and their patients depend on you. High quality, injectable
drugs—available when they need it—are not an option. At Dr. Reddy’s, we know
what it means to deliver on our promises. We are committed to making affordable
and innovative injectable medicines available to our customers. Our promises
are backed by high-quality system standards, sophisticated, real-time supply
chain technology, and more than 20,000 committed employees who know that
Good Health Can’t Wait.
© Dr. Reddy’s Laboratories, Inc. All rights reserved. RDY-1018-219
Dr. Reddy’s Laboratories, Inc. | 107 College Road East, Princeton, NJ 08540 | Tel: 866-733-3952
For more information visit pppmag.com/info www.drreddys.comPage 8 Pharmacy Purchasing Outlook - November 2019
Generic Approvals & News This product will be manufactured and
supplied by Natco Pharma to Brecken-
Continued from Page 6 ridge, for Breckenridge’s marketing, sale,
and distribution.
venture company Aleor Dermaceuticals Ltd. (also of Gujurat,
India) has received final FDA approval for its Abbreviated Fluoxetine Tablets Launch -
New Drug Application (ANDA) of Desonide Ointment 0.05%. Teva Pharmaceuticals
This product compares to Desonide Ointment 0.05% by On November 12, Teva Pharmaceuti-
Perrigo New York, Inc., which had 2018 U.S. sales of $13 cals USA, Inc. of North Wales, Penn-
million, according to IQVIA. It is a low potency cortico- sylvania announced their launch of
steroid indicated for the relief of the inflammatory and pruritic Fluoxetine Tablets, as detailed below.
manifestations of corticosteroid responsive dermatoses. 10mg: 30-count (NDC #00093-
7188-56); 100-count (NDC #00093-
Divalproex Sodium ER Tablets - Lupin Pharmaceuticals 7188-01); and 1,000-count bottles
On October 22, Lupin Pharmaceuticals, Inc. of Baltimore, (NDC #00093-7188-10).
Maryland announced they have received final FDA approval 20mg: 30-count (NDC #00093-
for Divalproex Sodium ER (extended-release) Tablets 250mg 0807-56) and 100-count bottles
and 500mg. (NDC #00093-0807-01).
This product compares to Depakote® ER Tablets by AbbVie 60mg: 30-count bottles (NDC
Inc., which had recent annual U.S. sales (ending June 2019) #00093-5262-56).
of $159 million, according to IQVIA. It is indicated as follows: This product compares to Prozac®
Acute treatment of manic or mixed episodes associated with Tablets by Eli Lilly & Company. It is
bipolar disorder, with or without psychotic features; indicated for the treatment of major
Monotherapy and adjunctive therapy of complex partial depressive disorder, bulimia nervosa (an
seizures and simple and complex absence seizures; eating disorder), obsessive-compulsive
adjunctive therapy in patients with multiple seizure types disorder, panic disorder, and premen-
that include absence seizures; strual dysphoric disorder.
Prophylaxis of migraine headaches.
Fosaprepitant For Injection Launch -
Erlotinib HCl Tablets - Breckenridge Pharmaceuticals Fresenius Kabi
On November 12, Breckenridge Pharmaceuticals, Inc. of On November 13, Fresenius Kabi USA,
Berlin, Connecticut announced their partner, Natco Pharma Ltd. LLC of Lake Zurich, Illinois announced
of Hyderabad, India, received final FDA approval of its the launch of Fosaprepitant for Injection
Abbreviated New Drug Application (ANDA) for Erlotinib HCl 150mg per vial; which offers a 24-month
Tablets 25mg, 100mg, and 150mg. shelf life.
Erlotinib HCl compares to Tarceva® Tablets by Genentech This product compares to Emend® for
USA, Inc. It is a kinase inhibitor indicated for the following. Injection by Merck Sharp & Dohme
The treatment of patients with metastatic non-small cell lung Corp. It is a substance P/neurokinin-1
cancer (NSCLC) whose tumors have epidermal growth (NK1) receptor antagonist, indicated in
factor receptor (EGFR) exon 19 deletions or exon 21 substi- adults, in combination with other
tution mutations as detected by an FDA-approved test; antiemetic agents, for the prevention of
receiving first-line, maintenance, or second or greater line the following:
treatment after progression following at least 1 prior Acute and delayed nausea and vomit-
chemotherapy regimen. ing associated with the initial and re-
First-line treatment of patients with locally advanced, peat courses of highly emetogenic
unresectable or metastatic pancreatic cancer, in combination cancer chemotherapy, including high-
with gemcitabine. dose cisplatin;
Recent annual U.S. sales of both the brand and its generic Delayed nausea and vomiting that are
equivalents (ending September 2019) were $145 million, associated with initial and repeat
according to IQVIA. courses of moderately emetogenic
cancer chemotherapy.Pharmacy Purchasing Outlook - November 2019 Page 9
John Ducker, President & CEO of Fre-
Generic Approvals & News senius Kabi USA, stated: “Fresenius Kabi
Continued from Page 8 is focused on expanding our Heparin and
Simplist prefilled syringe portfolios with
Haloperidol Decanoate Injection - Zydus Pharmaceuticals this Simplist Heparin prefilled syringe.
On October 24, Zydus Pharmaceuticals, Inc. of Pennington, By combining a small-volume presenta-
New Jersey announced they received final FDA approval of tion of Heparin with our other convenient
Haloperidol Decanoate Injection 50mg/mL and 100mg/mL in ready-to-administer prefilled syringes,
single-dose vials; and 250mg/5mL (50mg/mL) and 500mg/5mL this product will support safe practices
(100mg/mL) in multiple-dose vials. for this high-alert Medication.”
This product compares to Haldol® Injection by Janssen
Pharmaceuticals, Inc. It is indicated in the treatment of Levothyroxine Sodium Tablets -
schizophrenia, and for the control of tics and vocal utterances Lupin Pharmaceuticals
with Tourette’s syndrome. On November 1, Lupin Pharmaceuti-
cals, Inc. of Baltimore, Maryland an-
Heparin Sodium Injection PF Launch - Fresenius Kabi nounced they have received final FDA
On November 8, Fresenius Kabi USA, LLC of Lake Zurich, approval of a supplemental Abbreviated
Illinois announced their launch of Heparin Sodium Injection New Drug Application (sANDA) for
5,000 units per 0.5mL preservative-free (PF), in Simplist® Levothyroxine Sodium Tablets in the
ready-to-administer prefilled syringes. following strengths: 25mcg, 50mcg,
This product is considered to be a “high-alert” medication. 75mcg, 88mcg, 100mcg, 112mcg,
According to the Institute for Safe Medication Practices 125mcg, 137mcg, 150mcg, 175mcg,
(ISMP), high-alert medications are defined as: “Drugs that bear 200mcg, and 300mcg.
a heightened risk of causing significant patient harm when This product compares to Levoxyl®
they are used in error. Although mistakes may or may not be Tablets (in the same dosage strengths)
more common with these drugs, the consequences of an error by King Pharmaceuticals Research &
are clearly more devastating to patients.” Development LLC, a Pfizer company.
Heparin Sodium is an anticoagulant, indicated as follows. Originally, Lupin’s product was FDA-
Prophylaxis and treatment of venous thromboembolism and approved on January 18, 2019, as a
pulmonary embolism. generic equivalent to Synthroid® Tablets
Prevention of postoperative deep venous thrombosis and by AbbVie, Inc.
pulmonary embolism in patients who are undergoing major Then Lupin also received an sANDA
abdominothoracic surgery or who, for other reasons, are approval dated September 19, 2019 for its
at risk of developing thromboembolic disease. Levothyroxine Sodium Tablets, for a
Atrial fibrillation with embolization. generic equivalent of Unithroid® Tablets
Treatment of acute and chronic consumptive by Jerome Stevens Pharmaceuticals Inc.
coagulopathies (disseminated intravascular coagulation). With this newest sANDA approval,
Prevention of clotting in arterial and cardiac surgery. Lupin’s Levothyroxine Sodium Tablets in
Prophylaxis and treatment of peripheral arterial embolism. strengths noted above, is now AB-rated to
Use as an anticoagulant in blood transfusions, extra- Synthroid, Unithroid, and Levoxyl
corporeal circulation, and dialysis procedures. Tablets. It is the only product approved
Fresenius Kabi manufactures Simplist Heparin prefilled with the FDA’s new Narrow Therapeutic
syringes in the United States (although the drug’s active Index guidance for Levothyroxine.
pharmaceutical ingredient is sourced from Europe). Lupin’s Levothyroxine Sodium Tablets
In addition to this new prefilled syringe presentation, are indicated as follows.
Fresenius Kabi also offers Heparin Sodium Injection 5,000 Hypothyroidism: As replacement
units per 1mL in a Simplist prefilled syringe, along with therapy in primary (thyroidal),
Heparin Sodium in 5 freeflex® premix ready-to-administer secondary (pituitary), and tertiary
containers and 11 vial presentations. (hypothalamic) congenital or ac-
quired hypothyroidism.
Continued on Page 10Page 10 Pharmacy Purchasing Outlook - November 2019
Generic Approvals
Strides’ Ranitidine Tablets 300mg were
Continued from Page 9
tested and found to be within the accept-
Pituitary Thyrotropin (thyroid-stimulating hormone, TSH) able limits for NDMA of 96 nanograms
Suppression: As an adjunct to surgery and radioiodine per day or 0.32ppm.
therapy in the management of thyrotropin-dependent Strides has now completed comprehen-
well-differentiated thyroid cancer. sive testing of several of its batches that
Cumulatively, Levothyroxine Sodium Tablets (Synthroid, are available on the market and in stock,
Unithroid, and Levoxyl) had recent annual U.S. sales (ending which all meet the limits prescribed by
June 2019) of $2.58 billion, according to IQVIA. the FDA. Based on these outcomes, the
company has decided to re-launch its
Metoprolol Succinate ER Tablets Launch - product with immediate effect.
Recent annual U.S. sales for Ranitidine
TWi Pharmaceuticals
Tablets 150mg and 300mg were $76 mil-
On November 1, TWi Pharmaceuticals USA, Inc. of
lion, according to IQVIA.
Paramus, New Jersey announced their launch of Metoprolol
Succinate ER (extended-release) Tablets 25mg, 50mg, 100mg,
and 200mg. Zileuton ER Tablets -
This product compares to Toprol-XL® ER Tablets by Lupin Pharmaceuticals
AstraZeneca, which had recent annual U.S. sales (ending On November 8, Lupin Pharmaceuticals,
September 2019) of $554 million, according to IQVIA. Inc. of Baltimore, Maryland announced
Metoprolol Succinate ER is indicated for the treatment of they have received final FDA approval
hypertension (high blood pressure). for Zileuton ER (extended-release) Tablets
600mg.
Potassium Chloride (KCl) For Oral Solution Launch - This product compares to Zyflo CR® ER
Tablets by Chiesi USA, Inc., which had
Lupin Pharmaceuticals
recent annual U.S. sales (ending September
On November 19, Lupin Pharmaceuticals, Inc. of Baltimore,
2019) of $43 million, according to IQVIA.
Maryland announced their launch of Potassium Chloride
It is indicated for prophylaxis and chronic
(KCl) for Oral Solution 20mEq; having received earlier
treatment of asthma in adults and children
FDA-approval.
12 years of age and older.
This product is indicated for the treatment and prophylaxis
of hypokalemia with or without metabolic alkalosis in
patients for whom dietary management with potassium-rich
foods or diuretic dose reduction is insufficient.
Potassium Chloride for Oral Solution 20mEq had recent
annual U.S. sales (ending September 2019) of approximately
$90 million, according to IQVIA.
Ranitidine Tablets Re-Launch - Strides Pharma
On November 8, Strides Pharma, Inc. of East Brunswick,
New Jersey announced their re-launch of Ranitidine Tablets
150mg and 300mg.
The FDA had tested numerous ranitidine tablets on the
market over the past few months and released a summary
of the results on November 1, 2019. The agency had indicated
that if the levels of N-nitrosodimethylamine (NDMA) were
above the acceptable limits (96 nanograms per day or
0.32ppm), they are asking companies to recall ranitidine
products voluntarily (see October 2019 PPO).Supporting Pharmacy Efficiency and Patient Safety
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10211921 5517206 3795689 584466 Fluoxetine Oral Solution, USP 20mg/5mL 5mL 20mg/5mL 40 cups 60687-0244-77
10188404 5465380 3917226 363275 Fluoxetine Oral Solution, USP 20mg/5mL 5mL 20mg/5mL 50 cups 60687-0244-67
10228115 5552237 3968229 752410 Hydrocodone Bitartrate & APAP Oral Solution CII 7.25mg/325mg/15mL 15mL 7.25mg/325mg/15mL 50 cups 60687-0417-71
10211783 5517214 3901766 584557 Levetiracetam Oral Solution, USP 100mg/mL 5mL 500mg/5mL 40 cups 60687-0249-77
10183100 5430343 3775822 238550 Levetiracetam Oral Solution, USP 100mg/mL 5mL 500mg/5mL 50 cups 60687-0249-67
10210354 5512413 3777034 568063 Ondansetron Oral Solution, USP 4mg/5mL 5mL 4mg/5mL 30 cups 60687-0252-86
10219153 5528518 3949997 603993 Oxycodone HCl Oral Solution CII, USP 5mg/5mL 5mL 5mg/5mL 40 cups 60687-0406-77
10219154 5528526 3950037 604306 Oxycodone HCl Oral Solution CII, USP 5mg/5mL 5mL 5mg/5mL 50 cups 60687-0406-67
10209414 5508114 3751294 560649 Phenytoin Oral Suspension, USP 125mg/5mL 4mL 100mg/4mL 50 cups 60687-0275-66
10211558 5515705 3935129 575878 Potassium Chloride Oral Solution, USP 10% 20mEq/15mL 15mL 20mEq/15mL 30 cups 60687-0341-58
10212031 5520416 3909884 584904 Potassium Chloride Oral Solution, USP 10% 20mEq/15mL 15mL 20mEq/15mL 40 cups 60687-0341-64
10191061 5486220 3263035 321570 Potassium Chloride Oral Solution, USP 10% 20mEq/15mL 15mL 20mEq/15mL 50 cups 60687-0341-71
10211557 5515713 3935137 575894 Potassium Chloride Oral Solution, USP 10% 20mEq/15mL 15mL 20mEq/15mL 80 cups 60687-0341-07
10212749 5521521 3937786 591016 Potassium Chloride Oral Solution, USP 10% 20mEq/15mL 30mL 40mEq/30mL 40 cups 60687-0341-14
10191066 5487574 3266467 465344 Potassium Chloride Oral Solution, USP 10% 20mEq/15mL 30mL 40mEq/30mL 50 cups 60687-0341-72
10214626 5525027 3944592 594978 Ranitidine Syrup (Ranitidine Oral Solution, USP) 15mg/mL 10mL 150mg/10mL 40 cups 60687-0260-23
10182932 5427489 3772381 231142 Ranitidine Syrup (Ranitidine Oral Solution, USP) 15mg/mL 10mL 150mg/10mL 50 cups 60687-0260-69
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T10478Page 12 Pharmacy Purchasing Outlook - November 2019
Discontinued Drugs Divalproex Sodium ER Tablets
By Par Pharmaceuticals
Accupril® Tablets
On October 31, the FDA announced
On November 12, the FDA announced that Pfizer Inc. of
that Par Pharmaceuticals, Inc. of Wood-
New York City will discontinue the manufacture of Accupril®
cliff Lake, New Jersey has made a
(quinapril HCl) Tablets, 10x10 unit dose blister packs, in the
business decision to permanently discon-
following strengths.
tinue the manufacture of Divalproex
5mg: NDC #0071-0527-40.
Sodium ER (extended-release) Tablets,
10mg: NDC #0071-0530-40. in the following strengths.
20mg: NDC #0071-0532-40. 250mg: NDC #10370-510-10; NDC
This product is indicated to treat hypertension (high blood #10370-510-50.
pressure) and heart failure.
500mg: NDC #10370-511-10; NDC
#10370-511-50.
Azacitidine Injection By Teva This product is indicated for the treat-
On October 30, the FDA announced that Teva Pharma- ment of acute manic or mixed episodes
ceuticals USA, Inc. of North Wales, Pennsylvania has made associated with bipolar disorder, with or
a business decision to discontinue the manufacture of without psychotic features.
Azacitidine Injection 100mg/1 unit (NDC #0591-2897-49).
This product has not been marketed for an extended period
FazaClo® ODT Tablets
of time.
On November 22, the FDA announced
Azacitidine is indicated to treat certain types of bone marrow
that Jazz Pharmaceuticals, Inc. of
cancers and blood cell disorders.
Philadelphia, Pennsylvania has made a
commercial decision to discontinue the
Chlordiazepoxide HCl Capsules (C-IV) manufacture of FazaClo® (clozapine)
On November 19, the FDA announced that Bausch Health Orally Disintegrating Tablets (ODT), in
Companies Inc. of Bridgewater, New Jersey (distributed by the following strengths & presentations.
Solco Healthcare U.S., LLC) has made a business decision
12.5mg Blister Pack: NDC #18860-
to discontinue the manufacture of Chlordiazepoxide HCl
101-10.
Capsules, in the following strengths.
5mg: NDC #43547-251-10. 25mg Blister Pack: NDC #18860-
10mg: NDC #43547-252-10. 102-01.
25mg: NDC #43547-253-10. 25mg 100-Count Bottle:
This product has been classified by the U.S. Drug Enforce- NDC #18860-102-10.
ment Administration (DEA) as a Schedule 4 (C-IV) controlled 100mg Blister Pack: NDC #18860-
drug substance. It is indicated to treat anxiety disorders or 104-01.
withdrawal symptoms of alcoholism. 150mg Blister Pack: NDC #18860-
105-01.
Darifenacin Hydrobromide ER Tablets 150mg 100-Count Bottle:
By Par Pharmaceuticals NDC #18860-105-10.
On October 30, the FDA announced that Par Pharma- 200mg Blister Pack: NDC #18860-
ceuticals, Inc. of Woodcliff Lake, New Jersey has made a 106-01.
business decision to permanently discontinue the manufacture 200mg 100-Count Bottle:
of Darifenacin Hydrobromide ER (extended-release) Tablets, NDC #18860-106-10.
in the following strengths. This product is an antipsychotic medi-
7.5mg: NDC #10370-170-11; NDC #10370-170-09. cation indicated to treat severe
15mg: NDC #10370-171-11; NDC #10370-171-09. schizophrenia, or to reduce the risk of
This product is indicated to treat symptoms of overactive suicidal behavior in people with
bladder, such as frequent or urgent urination, and incontinence. schizophrenia or similar disorders.Pharmacy Purchasing Outlook - November 2019 Page 13
Discontinued Drugs 15Gm: NDC #0472-0163-15.
Continued from Page 12 30Gm: NDC #0472-0163-30.
This product is indicated to treat fungal
Integrilin® Injection By Merck/Novaplus® By Vizient infections of the skin.
On November 18, the FDA announced that Merck Sharp &
Dohme Corp. of Kenilworth, New Jersey will discontinue the Oxycodone HCl Tablets (C-II)
manufacture of Integrilin® (eptifibatide) Injection containing By Teva Pharmaceuticals
the Novaplus® private-label brand from Vizient, in the follow- On November 7, the FDA announced
ing strengths. that Teva Pharmaceuticals USA, Inc. of
0.75mg/mL: NDC #0085-1136-02; NDC #0085-1136-03. North Wales, Pennsylvania has made a
2mg/mL: NDC #0085-1177-03; NDC #0085-1177-05. business decision to discontinue the
However note that the following presentations will continue manufacture of Oxycodone HCl Tablets,
to be available: in the following strengths.
0.75mg/mL: NDC #0085-1136-01. 5mg/1 unit: NDC #0228-2876-11.
2mg/mL: NDC #0085-1177-01; NDC #0085-1177-02. 15mg/1 unit: NDC #0228-2878-11.
This product is indicated to prevent blood clots or heart attack 30mg/1 unit: NDC #0228-2879-11.
in people with severe chest pain or other conditions, and in This product has been classified by the
those who are undergoing a procedure called angioplasty (to U.S. Drug Enforcement Administration
open blocked arteries). (DEA) as a Schedule 2 (C-II) controlled
drug substance. It is indicated to treat
Microzide® Capsules moderate to severe pain.
On October 22, the FDA announced that Allergan, Inc. of Note: this product was originally
Madison, New Jersey will discontinue the manufacture of manufactured by Actavis (now owned
Microzide® (hydrochlorothiazide) Capsules 12.5mg (NDC by Teva Pharmaceuticals).
#52544-622-01).
However, the Authorized Generic (AG) of this product, Paclitaxel Injection By Mylan
Hydrochlorothiazide Capsules 12.5mg is still available. On November 22, the FDA announced
This product is indicated to treat fluid retention (edema) in that in December 2019 Mylan Institu-
people with congestive heart failure, hypertension, cirrhosis of tional, Inc. of Canonsburg, Pennsylvania
the liver, kidney disorders, or edema caused by taking steroids will discontinue the manufacture of
or estrogen. Paclitaxel Injection 100mg in 16.7mL
Note: this item is distributed by Watson Pharma, now (6mg/mL) multi-dose vial (NDC #67457-
Actavis, Inc., part of the Allergan Pharmaceutical Company. 449-17).
This product is indicated to treat breast
Navelbine® Injection cancer, ovarian cancer, lung cancer, and
On November 8, the FDA announced that Pierre Fabre AIDS-related Kaposi’s sarcoma.
Pharmaceuticals, Inc. of Parsippany, New Jersey will discon-
tinue the manufacture of Navelbine® (vinorelbine tartrate) Pitocin® Synthetic 10mL Injection
Injection single dose glass vials, in the following strengths. On November 1, the FDA announced
10mg/mL: NDC #64370-532-01. that Par Pharmaceuticals, Inc. of Wood-
50mg/5mL: NDC #64370-532-02 (limited current cliff Lake, New Jersey has made a busi-
availability, with distribution to end December 31, 2019). ness decision to permanently discontinue
Navelbine Injection is indicated to treat non-small cell lung the manufacture of Pitocin® (oxytocin)
cancer (NSCLC). Synthetic 10mL Injection, single pack
vial (NDC #42023-116-01).
Nystatin Cream By Teva Pharmaceuticals Pitocin is a hormone medication that is
On November 15, the FDA announced that Teva Pharma- indicated to induce labor or strengthen
ceuticals USA, Inc. of North Wales, Pennsylvania has made a uterine contractions, or to control bleed-
business decision to discontinue the manufacture of Nystatin ing after childbirth.
Cream 100,000 units per gram, in the following strengths.
Continued on Page 14Page 14 Pharmacy Purchasing Outlook - November 2019
Biosimilar Drug Approvals NHL in combination with first line
chemotherapy and, in patients
achieving a complete or partial
Truxima® Injection, First Biosimilar To Rituxan® - response to a rituximab product in
Now Available combination with chemotherapy, as
On November 7, Teva Pharmaceuticals USA, Inc. of single-agent maintenance therapy;
Parsippany, New Jersey and Celltrion Inc. of Jersey City, New non-progressing (including stable
Jersey jointly announced that Truxima® (rituximab-abbs) disease), low-grade, CD20-positive,
Injection, the first biosimilar to Rituxan® (rituximab) by B-cell NHL as a single agent
Genentech and Biogen, is now available with a full oncology after first-line cyclophosphamide,
label; after its previous FDA approval late last year (see vincristine, and prednisone (CVP)
December 2018 PPO). chemotherapy; previously untreated
A biosimilar is a biological product that is highly similar to diffuse large B-cell, CD20-positive
an existing FDA-approved biological product, known as a NHL in combination with (cyclo-
reference product. The biosimilar must also have no clinically phosphamide, doxorubicin, vincri-
meaningful differences in terms of safety and effectiveness stine, and prednisone, CHOP), or
from the reference product. with other anthracycline based
Truxima has the same mechanism of action as Rituxan and chemotherapy regimens.
has demonstrated biosimilarity to Rituxan through a totality of b) Chronic Lymphocytic Leukemia
evidence. It is indicated for the treatment of adult patients with (CLL): in combination with fluda-
non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic rabine and cyclophosphamide (FC),
Leukemia (CLL), as follows. for the treatment of adult patients
a) Non-Hodgkin’s Lymphoma (NHL): relapsed or refractory, with previously untreated and previ-
low grade or follicular, CD20-positive B-cell NHLas a single ously treated CD20-positive CLL.
agent; previously untreated follicular, CD20-positive, B-cell In addition, due to a patent settlement
with Genentech, Celltrion and Teva
have a pending FDA submission for
rheumatoid arthritis (RA), granulomato-
Discontinued Drugs sis with polyangiitis (GPA), and micro-
Continued from Page 13 scopic polyangiitis (MPA), and a license
from Genentech, to expand the Truxima
Tizanidine HCl Tablets By Mylan label to include these indications in the
On November 21, the FDA announced that Mylan Pharma- second quarter of 2020.
ceuticals, Inc. of Canonsburg, Pennsylvania will be discontinu-
ing their manufacture of Tizanidine HCl Tablets, in the Ziextenzo™ Injection -
following strengths. Biosimilar To Neulasta®
4mg: NDC #0378-0724-19. On November 5, Sandoz Inc. of
2mg: NDC #0378-0722-19. Princeton, New Jersey (a Novartis divi-
This product is a muscle relaxer indicated to treat spasticity sion) announced the FDA approval
by temporarily relaxing muscle tone. of Ziextenzo™ (pegfilgrastim-bmez)
Injection for subcutaneous use, a
Valacyclovir HCl 1Gm Tablets By Teva biosimilar to Neulasta® (pegfilgrastim)
On November 15, the FDA announced that Teva Pharma- by Amgen, Inc.
ceuticals USA, Inc. of North Wales, Pennsylvania has made The product is expected to be avail-
a business decision to discontinue the manufacture of able as soon as possible after this
Valacyclovir HCl Tablets 1Gm (NDC #0093-7259-98 and announcement date.
NDC #0093-7259-56. Ziextenzo is indicated to decrease the
This product is an antiviral drug, indicated to slow the incidence of infection, as manifested by
growth and spread of the herpes virus and help the body to febrile neutropenia (low white blood
fight the infection. cell count with a fever), in patients with
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Issue: OctoberPage 16 Pharmacy Purchasing Outlook - November 2019
Biosimilar Drug Approvals New Drugs/Indications
Continued from Page 14
Adakveo® To Reduce Frequency Of
non-myeloid malignancies receiving myelosuppressive Pain Crises With Sickle Cell Disease
anti-cancer drugs associated with a clinically signifi- On November 15, Novartis Pharmaceuticals
cant incidence of febrile neutropenia. Corporation of East Hanover, New Jersey an-
The recommended dosage and administration for nounced the FDA has approved Adakveo®
patients with cancer receiving myelosuppressive (crizanlizumab), indicated to reduce the fre-
chemotherapy is 6mg, administered subcutaneously quency of vaso-occlusive crises (VOCs), or pain
once per chemotherapy cycle. It should not be crises, in adult and pediatric patients aged 16
administered between 14 days before and 24 hours years and older with sickle cell disease.
after administration of cytotoxic chemotherapy; and Product is expected to be available in the
weight-based dosing should be used for pediatric coming weeks after this announcement date.
patients weighing less than 45kg. The recommended dose is 5mg/kg intravenously
Pegfilgrastim is a long-acting form of filgrastim. over a period of 30 minutes on week 0, 2, and
Filgrastim is very similar to a natural protein every 4 weeks thereafter.
(granulocyte-colony stimulating factor), also known Adakveo represents the first FDA-approved
as G-CSF, produced by a person’s own body. Febrile medicine in sickle cell disease that binds to
neutropenia is caused by cytotoxic chemotherapy P-selectin, a cell adhesion protein that plays a
(medicines that destroy rapidly growing cells); central role in the multicellular interactions that
white blood cells are important as they help your can lead to vaso-occlusion.
body fight infection. The FDA granted this application Priority Re-
A study has shown that each year in the U.S., view, Breakthrough Therapy, and Orphan Drug
more than 60,000 cancer patients are hospitalized with designation. Richard Pazdur, M.D., Director of
evidence of neutropenia, including fever or infection, the FDA’s Oncology Center of Excellence and
with more than 4,000 deaths as a result. Acting Director of the Office of Oncologic Dis-
Sandoz is now the first and only company to offer eases in the FDA’s Center for Drug Evaluation &
physicians in the U.S. the choice between a long and Research, noted: “Adakveo is the first targeted
short-acting biosimilar filgrastim treatment to best suit therapy approved for sickle cell disease, specifi-
the individual needs of tens of thousands of patients cally inhibiting selectin, a substance that con-
undergoing chemotherapy. tributes to cells sticking together and leads to
Carol Lynch, President of Sandoz Inc., stated: vaso-occlusive crisis. Vaso-occlusive crisis can
“When a cancer patient with febrile neutropenia gets be extremely painful and is a frequent reason
an infection, it can have serious consequences such for Emergency Department visits and hospital-
as delays or dose reductions of chemotherapy. The ization for patients with sickle cell disease.”
approval of Ziextenzo expands our oncology portfolio, Sickle cell disease is a complex and debilitat-
providing physicians with a long-acting supportive ing, genetic blood disorder that goes beyond
oncology biosimilar option. It builds on the foundation sickle-shaped red blood cells. The disease is
of trust and experience we developed with our short- associated with chronic inflammation, causing
acting filgrastim Zarxio®, including consistent product higher levels of cell adhesion proteins, including
supply and reliable patient services.” P-selectin, which make both the blood vessels
Sandoz has proven biosimilars create early and and certain blood cells stickier and prone to
expanded patient access to life-changing biologics multicellular interactions, or clusters, in the
while increasing healthcare savings. Ziextenzo can bloodstream. This environment can lead to the
help increase positive treatment outcomes for patients acute episodes of pain known as sickle cell pain
undergoing chemotherapy and drive significant savings crises, or VOC’s, as well as life-threatening com-
for the healthcare system. plications. VOC’s are the main reason why
individuals living with sickle cell disease seek
medical care in hospitals, leading to approxi-
mately 200,000 ER visits in the U.S. every year.Pharmacy Purchasing Outlook - November 2019 Page 17
New Drugs/Indications
Continued from Page 16
Beverley Francis-Gibson, President & CEO of the Sickle Cell Disease Association of America,
commented: “Patients with sickle cell disease often face unique challenges, and have long suffered
silently through unimaginable pain crises. We are excited to have a new medicine that may help
many of the thousands of people living with sickle cell disease by reducing the frequency of these
potentially dangerous and painful episodes.”
Approximately 100,000 people in the U.S. have sickle cell disease. People of African ancestry
make up 90% of the population with sickle cell disease in the United States. However, sickle cell
disease is also prevalent among people of Hispanic, South Asian, Southern European, and Middle
Eastern ancestry. The disease occurs in about 1 in 365 and 1 in 16,300 African-American and
Hispanic-American births, respectively.
Admiral Brett P. Giroir, M.D., Acting Commissioner of the FDA, said: “Hope has never been
higher for people living with sickle cell disease and their families and supporters, with a pipeline of
new treatments on the horizon, like the one now being approved (Adakveo) as well as several
initiatives underway to better utilize current tools in the battle against the painful and deadly blood
disorder. The opportunity before us in the coming months and years is profound and historic.”
Baxdela® - For Community-Acquired Bacterial Pneumonia - New Indication
On October 24, Melinta Therapeutics, Inc. of Morristown, New Jersey announced the FDA has
approved a new indication for Baxdela® (delafloxacin) Tablets and Intravenous (IV) Injection,
now also for the treatment of adult patients with community-acquired bacterial pneumonia that is
caused by designated susceptible bacteria.
Product availability is unclear at this time, however Melinta will announce an update as soon as
they have news.
Community-acquired bacterial pneumonia (CABP) is pneumonia that is acquired outside the
hospital setting. It is caused by one of the more common bacteria or viruses, such as the following
susceptible microorganisms: Streptococcus pneumoniae; Staphylococcus aureus (methicillin-
susceptible isolates only); Klebsiella pneumoniae; Escherichia coli; Pseudomonas aeruginosa;
Haemophilus influenzae; Haemophilus parainfluenzae; Chlamydia pneumoniae; Legionella
pneumophila; Mycoplasma pneumoniae.
This supplemental approval was given Priority Review by the FDA due to its designation as
a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now
(GAIN) Act of 2012. The QIDP designation qualifies Baxdela for certain incentives related to the
development of new antibiotics, including a 5-year extension of any non-patent exclusivity period
awarded to the drug.
Previously, Baxdela was FDA-approved in 2017, for the treatment of adult patients with acute
bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
Botox® For Pediatric Patients With Lower Limb Spasticity - New Indication
On October 24, Allergan, Inc. of Madison, New Jersey announced the FDA approved their
supplemental Biologics License Application (sBLA) of a new indication for Botox® for Injection,
now also for the treatment of pediatric patients (2 to 17 years of age) with lower limb spasticity,
excluding spasticity caused by cerebral palsy.
Spasticity is a debilitating neurological condition involving muscle stiffness that can result in tight
muscles in the upper and lower limbs, and can interfere with movement. The severity can range
from mild to severe muscle stiffness.
This marks the 11th therapeutic indication of Botox, having been approved for pediatric upper limb
spasticity earlier this year.
Continued on Page 18Page 18 Pharmacy Purchasing Outlook - November 2019
New Drugs/Indications
Continued from Page 17
The approved recommended dose per treatment session is 4 Units/kg to 8 Units/kg divided
among affected muscles of the lower limb. The total dose per treatment session in the lower limb
should not exceed 8 Units/kg or 300 Units, whichever is lower. When treating both lower limbs
or upper and lower limbs in combination, the total dose in pediatric patients should not exceed
10 Units/kg body weight or 340 Units, whichever is lower, in a 3-month interval.
David Nicholson, Chief Research & Development Officer for Allergan, said: “Lower limb
spasticity can impact many aspects of a child’s life and have a drastic influence on their overall
development and quality of life. This milestone will continue to support and advance care for
children and their caregivers who may be struggling with lower limb spasticity.”
Mark Gormley, Jr., M.D., Pediatric Rehabilitation Medicine Specialist with Gillette Children’s
Specialty Healthcare in St. Paul, Minnesota, explained: “Pediatric lower limb spasticity inhibits
normal muscular movement and function and can result in delayed or impaired motor development,
as well as difficulty with posture and positioning. Botox has a well-established safety and
efficacy profile, and supports children and adolescents successfully manage both their upper and
lower limb spasticity.”
Brukinsa™ For Adults With Mantle Cell Lymphoma
Who Received At Least 1 Prior Therapy
On November 14, BeiGene, Ltd. of Beijing, China (with U.S. incorporated headquarters in
Cambridge, Massachusetts) announced the FDA has granted accelerated approval for Brukinsa™
(zanubrutinib) Capsules, a kinase inhibitor indicated for the treatment of mantle cell lymphoma
in adult patients who have received at least one (1) prior therapy.
Product is expected to be available in the coming weeks after this announcement date.
The recommended dose of Brukinsa is 320mg, taken orally 160mg twice daily or 320mg once daily
with or without food. It can be adjusted for adverse reactions, and reduced for patients with severe
hepatic impairment and certain drug interactions.
Lymphoma is a diverse group of cancers that originate from B, T or NK cells. Mantle Cell
Lymphoma (MCL) is typically an aggressive form of non-Hodgkin’s lymphoma (NHL) that
arises from B-cells originating in the “mantle zone.” In the United States, about 74,200 people
will be diagnosed with NHL in 2019, with MCL representing about 6% (about 4,452 cases) of
all new cases of NHL. MCL usually has a poor prognosis, with a median survival of 3 to 4 years,
and it often diagnosed at a later stage of disease.
Luhua (Michael) Wang, M.D., Professor of the Lymphoma & Myeloma Department in the
Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in
Houston (and the product’s trial investigator), said: “BTK inhibition is an established mode of
treatment for patients with MCL, but many patients treated with previously approved BTK
inhibitors do not fully respond to BTK therapy or are forced to discontinue treatment early due
to side effects. Now we have a new option for our adult patients who have received one prior
systemic or targeted therapy and are living with MCL, an aggressive blood cancer that’s often
diagnosed at a more advanced stage.”
The FDA granted Brukinsa with Accelerated Approval, Breakthrough Therapy, and Orphan
Drug designation.
Richard Pazdur, M.D., Director of the FDA’s Oncology Center of Excellence and Acting Director
of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation & Research, said:
“Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or stops
responding, and the cancer cells continue to grow. This is a life-threatening condition. Clinical trials
Continued on Page 20You can also read
