HORIZON LINES: A QUARTERLY REVIEW OF NDAs SECTION TITLE
Approval date (2016)
March 11 March 16 March 18 March 22 March 23
Trade Name Drug Name Dosage Form Xalkori Kovaltry Crizotinib
Antihemophilic factor
Anthim Obiltoxaximab Taltz Cinqair March 30 Defitelio April 4 April 5 April 8 April 11 April 15 April 25 April 25 Descovy Ixekizumab Reslizumab Defibrotide
Emtricitabine and tenofovir alafenamide
Capsule Injection Injection Injection
Company Pfizer Inc
Bayer HealthCare Pharmaceuticals Inc.
Elusys Therapeutics, Inc. Eli Lilly and Company Injection Teva Pharmaceutical Industries Ltd. Injection Tablets Inflectra Infliximab-dyyb Injection BromSite Venclexta
Gilotrif Bevespi
Aerosphere Bromfenac Venetoclax Afatinib
Formoterol and Glycopyrrolate
Cabometyx Cabozantinib April 26 Xtampza ER Oxycodone April 29 April 29 April 29 April 29 April 29 Nuplazid Gadavist Pimavanserin Gadobutrol
ProAir RespiClick Albuterol sulphate
Ophthalmic Solution
Tablet Tablet
Metered dose inhaler
Tablets
Extended- Release Capsules
Tablets Injection
Inhalation powder
Akovaz Ephedrine sulfate Injection Ciprofloxacin
Otovel
and Fluocinolone Acetonide
Otic Solution Jazz Pharmaceuticals plc Gilead Sciences Inc Celltrion Inc
Indication lung cancer Hemophilia A
Anthrax Prophylaxis, Anthrax
Plaque Psoriasis Asthma Hepatic Veno- Occlusive Disease HIV Infection Crohn's Disease
Sun Pharmaceutical Industries Ltd. Postoperative Ocular Inflammation
AbbVie Inc
Boehringer Ingelheim Pharmaceuticals
AstraZeneca Pharmaceuticals LP Exelixis Inc Collegium Pharmaceutical, Inc Acadia Pharmaceuticals Inc
Bayer HealthCare Pharmaceuticals Inc
Teva Pharmaceutical Industries Ltd. Flamel Technologies
Laboratorios Salvat S.A. and Arbor Pharmaceuticals, LLC
Chronic Lymphocytic Leukemia
non-small cell lung cancer
Chronic Obstructive Pulmonary Disease
Renal Cell Carcinoma Chronic Pain
Parkinson’s Disease Psychosis
Diagnosis and Investigation
Asthma Hypotension
Acute Otitis Media with
Tympanostomy Tubes
pharmoutsourcing.com | 45 | November/December 2016
Comment It is the first and only FDA approved
treatment for patients with ROS-1 positive Non-small cell lung cancer.
Can be used two or three times per week in and every other day in children.
Inhalational anthrax is a rare disease that can occur after exposure to infected animals or contaminated animal products.
Inhibits the inflammatory response that plays a role in the development of plaque psoriasis.
Maintenance treatment of severe asthma in patients aged 18 years and older.
Significant for patients receiving chemotherapy and hematopoietic stem cell transplantation.
Descovy has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly.
This is the second biosimilar approved by the FDA.
First Bromfenac ophthalmic solution.
For patients with chromosomal abnormality and who have been treated with at least one prior therapy.
Approved for squamous cell carcinoma of lung.
First LAMA/LABA in a pressurized metered-dose inhaler.
For patients with previously treated advanced kidney cancer.
Utilizes DETERx® technology platform.
Treat hallucinations and delusions associated with psychosis.
Approved for use with Magnetic Resonance Angiography of Supra-Aortic Arteries.
For children 4 to 11 years of age.
Expected to launch during the third quarter 2016 in a strength of 50 mg/mL.
Otovel is owned by Salvat, and Arbor will be the exclusive distributor of the product.
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