New Drug Approvals
The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.
See also: Generic Approvals, Approval Process, New Indications and Dosage forms
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Amjevita (adalimumab-atto) - formerly ABP 501
Company: Amgen Inc.
Date of Approval: September 23, 2016
Treatment for: Plaque Psoriasis, Rheumatoid Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohn's Disease -- Maintenance, Psoriatic Arthritis
Amjevita (adalimumab-atto) is biosimilar to Humira, an anti-TNF-α monoclonal antibody approved for the treatment of various inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
- FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira - September 23, 2016
- Amgen To Discuss Data Supporting Biologics License Application For ABP 501, A Biosimilar Candidate To Adalimumab - July 12, 2016
- Amgen Announces FDA Advisory Committee Meeting To Review ABP 501, A Biosimilar Candidate To Adalimumab - June 13, 2016
- FDA Accepts Amgen's Biosimilar Biologics License Application For ABP 501 - January 25, 2016
- Amgen's First Biosimilar Biologics License Application for ABP 501 Submitted to FDA - November 25, 2015
Exondys 51 (eteplirsen)
Company: Sarepta Therapeutics
Date of Approval: September 19, 2016
Treatment for: Duchenne Muscular Dystrophy
Exondys 51 (eteplirsen) is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.
- FDA Approves Exondys 51 (eteplirsen) for Duchenne Muscular Dystrophy - September 19, 2016
- Sarepta Therapeutics Announces FDA Request For Dystrophin Data Prior To Making A Decision on Eteplirsen NDA - June 6, 2016
- Sarepta Therapeutics Announces FDA Will Not Complete the Review of the Eteplirsen NDA By The PDUFA Date - May 25, 2016
- Sarepta Issues Statement on Advisory Committee Outcome for Use of Eteplirsen in the Treatment of Duchenne Muscular Dystrophy - April 25, 2016
- Sarepta Therapeutics Receives Notification of PDUFA Extension for Eteplirsen - February 8, 2016
- Sarepta Therapeutics Announces FDA Has Filed Eteplirsen NDA for the Potential Treatment of Duchenne Muscular Dystrophy for Patients Amenable to Exon 51 Skipping - August 25, 2015
- Sarepta Therapeutics Completes NDA Submission to FDA for Eteplirsen - June 29, 2015
- Sarepta Therapeutics Announces Regulatory Update on Eteplirsen - October 27, 2014
- Sarepta Therapeutics Announces Plans to Submit NDA to FDA for Eteplirsen for Duchenne Muscular Dystrophy - April 21, 2014
- Sarepta Therapeutics Announces FDA Considers NDA Filing for Eteplirsen Premature in Light of Recent Competitive Drug Failure and Recent DMD Natural History Data - November 12, 2013
- Sarepta Therapeutics Announces Plans to Submit New Drug Application to FDA for Eteplirsen for the Treatment of Duchenne Muscular Dystrophy in First Half of 2014 - July 25, 2013
Kyleena (levonorgestrel) Releasing Intrauterine System
Company: Bayer HealthCare Pharmaceuticals Inc.
Date of Approval: September 16, 2016
Treatment for: Contraception
Kyleena (levonorgestrel-releasing intrauterine system) is a low-dose progestin-containing intrauterine system (IUS) indicated for the prevention of pregnancy for up to five years.
- FDA Approves Bayer's Kyleena (Levonorgestrel-Releasing Intrauterine System) for Prevention of Pregnancy for up to Five Years - September 19, 2016
Yosprala (aspirin and omeprazole) Delayed-Release Tablets
Company: Aralez Pharmaceuticals Inc.
Date of Approval: September 14, 2016
Treatment for: Ischemic Stroke -- Prophylaxis, Gastric Ulcer Prophylaxis
Yosprala (aspirin and omeprazole) is a platelet aggregation inhibitor and proton pump inhibitor combination indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.
- FDA Approves Yosprala (aspirin and omeprazole) for Secondary Prevention of Cardiovascular Disease in Patients at Risk for Aspirin-Associated Gastric Ulcers - September 15, 2016
- Aralez Resubmits to FDA New Drug Application for Yosprala - March 15, 2016
- Pozen’s Yosprala Receives Complete Response Letter from the FDA - December 17, 2014
Cuvitru (immune globulin subcutaneous (human)) Injection
Company: Shire US, Inc.
Date of Approval: September 13, 2016
Treatment for: Primary Immunodeficiency Syndrome
Cuvitru (immune globulin subcutaneous (human)) is indicated as replacement therapy in the treatment of primary humoral immunodeficiency (PI).
- Shire Announces FDA Approval of Cuvitru [immune globulin subcutaneous (human)] for Primary Immunodeficiency - September 14, 2016
Lomaira (phentermine hydrochloride) Tablets
Company: KVK-Tech, Inc.
Date of Approval: September 13, 2016
Treatment for: Weight Loss, Obesity
Lomaira (phentermine hydrochloride) is a sympathomimetic amine anorectic used short-term for weight reduction in overweight or obese adults.
- KVK Tech Announces FDA-Approval of Lomaira (phentermine hydrochloride USP) for Weight Reduction - September 20, 2016
Erelzi (etanercept-szzs) Injection
Company: Sandoz Inc.
Date of Approval: August 30, 2016
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis
Erelzi (etanercept-szzs) is a tumor necrosis factor (TNF) blocker biosimilar to Enbrel indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
- FDA Approves Erelzi (etanercept-szzs), a Biosimilar to Enbrel - August 31, 2016
Troxyca ER (naltrexone and oxycodone) Extended-Release Capsules - formerly ALO-02
Company: Pfizer Inc.
Date of Approval: August 19, 2016
Treatment for: Pain
Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) is an extended-release, abuse-deterrent, narcotic analgesic formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
- FDA Approves Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) Capsules with Abuse-Deterrent Properties for the Management of Pain - August 19, 2016
- Pfizer Announces FDA Advisory Committees’ Recommend ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release Capsules for Approval - June 8, 2016
- Pfizer Announces FDA Acceptance for Review of NDA for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) - February 13, 2015
Sustol (granisetron) Extended-Release Injection - formerly APF530
Company: Heron Therapeutics, Inc.
Date of Approval: August 9, 2016
Treatment for: Nausea/Vomiting -- Chemotherapy Induced
Sustol (granisetron) is a long-acting 5-HT3 antagonist indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.
- Heron Therapeutics Announces FDA Approval of Sustol (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting - August 10, 2016
- Heron Therapeutics Provides Update on FDA Review of Sustol NDA - April 18, 2016
- Heron Therapeutics Provides Update on Sustol NDA - March 3, 2016
- Heron Therapeutics Notified by FDA That It Will Not Take Action on Sustol New Drug Application by the PDUFA Date - January 15, 2016
- Heron Therapeutics Provides Update on Sustol Resubmission - January 27, 2014
- FDA Rejects A.P. Pharma's Cancer Drug - April 2, 2013
- A.P. Pharma Receives FDA Complete Response Letter for APF530 - March 29, 2013
- A.P. Pharma Announces PDUFA Action Date for APF530 New Drug Application Resubmission - October 16, 2012
- A.P. Pharma Provides Regulatory Update on APF530 NDA - April 25, 2011
- A.P. Pharma Receives FDA Complete Response Letter for APF530 - March 19, 2010
- A.P. Pharma Announces FDA Acceptance of APF530 New Drug Application for Chemotherapy-Induced Nausea and Vomiting - July 20, 2009
- A.P. Pharma Submits New Drug Application for APF530 in Chemotherapy-Induced Nausea and Vomiting - May 18, 2009
Flonase Sensimist (fluticasone furoate) Nasal Spray
Company: GlaxoSmithKline Consumer Healthcare LP
Date of Approval: August 2, 2016
Treatment for: Allergic Rhinitis
Flonase Sensimist (fluticasone furoate) is an over-the-counter corticosteroid nasal spray indicated for the treatment of symptoms associated with seasonal and perennial allergies in adults and children ages 2 years and older.
- FDA Approves Flonase Sensimist Allergy Relief - August 2, 2016
Qbrelis (lisinopril) Oral Solution
Company: Silvergate Pharmaceuticals, Inc.
Date of Approval: July 29, 2016
Treatment for: Hypertension, Congestive Heart Failure, Myocardial Infarction
Qbrelis (lisinopril) is an oral solution formulation of the approved angiotensin converting enzyme (ACE) inhibitor lisinopril indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults.
- FDA Approves Qbrelis (lisinopril) Oral Solution for Pediatric Patients 6 Years of Age and Older - July 29, 2016
Adlyxin (lixisenatide) Injection - formerly Lyxumia
Company: Sanofi-Aventis U.S. LLC
Date of Approval: July 27, 2016
Treatment for: Diabetes Type 2
Adlyxin (lixisenatide) is a once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus.
- Sanofi Receives FDA Approval of Adlyxin (lixisenatide) for Treatment of Adults With Type 2 Diabetes - July 27, 2016
- Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA - September 29, 2015
- Sanofi Reports Positive Top-Line Results In Second Pivotal Lixilan Phase III Study - September 14, 2015
- Sanofi's Lyxumia (lixisenatide) Demonstrated Cardiovascular Safety in People With Type 2 Diabetes and High CV Risk - June 8, 2015
- Lyxumia (Lixisenatide) Meets Co-Primary Endpoints in GetGoal Duo-2 Trial - June 6, 2015
- Sanofi Announces Top-Line Results for Cardiovascular Outcomes Study of Lyxumia (Lixisenatide) - March 19, 2015
- Sanofi's Lyxumia (lixisenatide) Showed More Pronounced After-Test-Meal Blood Sugar Lowering than Liraglutide when Both were Added to Insulin Glargine - June 14, 2014
- Sanofi Provides Update on Lixisenatide New Drug Application in U.S. - September 12, 2013
- Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA - February 19, 2013
Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) Extended-Release Tablets
Company: AbbVie Inc.
Date of Approval: July 22, 2016
Treatment for: Chronic Hepatitis C
Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) is a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor, NS5A inhibitor, NS3/4A protease inhibitor, and CYP3A inhibitor fixed-dose combination indicated for the once-daily treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1 infection.
Viekira XR FDA Approval HistoryXiidra (lifitegrast) Ophthalmic Solution
Company: Shire US, Inc.
Date of Approval: July 11, 2016
Treatment for: Dry Eye Disease
Xiidra (lifitegrast) is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease.
- FDA Approves Xiidra (lifitegrast ophthalmic solution) for Dry Eye Disease - July 12, 2016
- U.S. FDA Acknowledges Receipt of Resubmission of Shire’s NDA for Lifitegrast for Dry Eye Disease in Adults - February 4, 2016
- Shire Resubmits New Drug Application for Lifitegrast to U.S. FDA - January 25, 2016
- Shire Receives FDA Complete Response Letter for Lifitegrast NDA and Plans to Respond with OPUS-3 Trial - October 16, 2015
- U.S. FDA Grants Priority Review to Lifitegrast NDA for the Treatment of Dry Eye Disease in Adults - April 9, 2015
- Shire Submits NDA to the FDA for Approval of Lifitegrast For Treatment of Dry Eye Disease in Adults - March 2, 2015
- Shire Plans to Submit a New Drug Application to FDA for Lifitegrast for Dry Eye Disease in Adults - May 16, 2014
Syndros (dronabinol) Oral Solution
Company: Insys Therapeutics, Inc.
Date of Approval: July 1, 2016
Treatment for: Anorexia -- AIDS Patients; Nausea/Vomiting -- Chemotherapy Induced
Syndros (dronabinol) is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (THC) approved for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
Syndros FDA Approval HistoryKovanaze (oxymetazoline hydrochloride and tetracaine hydrochloride) Nasal Spray
Company: St. Renatus LLC
Date of Approval: June 29, 2016
Treatment for: Dental Anesthesia
Kovanaze (oxymetazoline hydrochloride and tetracaine hydrochloride) is a vasoconstrictor and local anesthetic combination administered intranasally as a topical anesthetic for use in restorative dental procedures.
- St. Renatus, LLC Announces FDA Approval of Kovanaze (tetracaine HCl and oxymetazoline HCl) Nasal Spray for Use in Dentistry - July 12, 2016
Epclusa (sofosbuvir and velpatasvir) Tablets
Company: Gilead Sciences, Inc.
Date of Approval: June 28, 2016
Treatment for: Chronic Hepatitis C
Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.
- FDA Approves Epclusa (sofosbuvir and velpatasvir) for Treatment of all Major Forms of Chronic Hepatitis C Virus Infection - June 28, 2016
- Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection - January 4, 2016
- Gilead Submits NDA to U.S. FDA for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C - October 28, 2015
Rayaldee (calcifediol) Extended Release Capsules
Company: OPKO Health, Inc.
Date of Approval: June 17, 2016
Treatment for: Secondary Hyperparathyroidism
Rayaldee (calcifediol) is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism associated with vitamin D Insufficiency in stage 3-4 chronic kidney disease.
- FDA Approves Rayaldee (calcifediol) to Treat Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease - June 21, 2016
- FDA Accepts Resubmission of New Drug Application for Rayaldee - April 27, 2016
- OPKO Receives Complete Response Letter from FDA for Rayaldee New Drug Application - March 30, 2016
- FDA Accepts OPKO's New Drug Application for Rayaldee - July 28, 2015
- OPKO Announces Submission of Rayaldee NDA - June 2, 2015
Vaxchora (cholera vaccine, live, oral) Suspension for Oral Administration
Company: PaxVax Inc.
Date of Approval: June 10, 2016
Treatment for: Cholera Prophylaxis
Vaxchora (cholera vaccine, live, oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults traveling to cholera-affected areas.
Vaxchora FDA Approval HistoryGoNitro (nitroglycerin) Sublingual Powder
Company: Espero Pharmaceuticals, Inc.
Date of Approval: June 8, 2016
Treatment for: Angina Pectoris Prophylaxis
GoNitro (nitroglycerin) is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
- Espero Pharmaceuticals Receives FDA Approval for GoNitro (nitroglycerin) Sublingual Powder - June 14, 2016
