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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Trulance (plecanatide) Tablets
Company: Synergy Pharmaceuticals Inc.
Date of Approval: January 19, 2017
Treatment for: Constipation -- Chronic
Trulance (plecanatide) is a uroguanylin analog for the treatment of chronic idiopathic constipation.
- FDA Approves Trulance (plecanatide) for Chronic Idiopathic Constipation - January 19, 2017
- Synergy Pharmaceuticals Announces Positive Results in First Phase 3 Trial of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C) - December 9, 2016
- Synergy Pharmaceuticals Provides Update on Ongoing FDA Review of Plecanatide CIC NDA and IBS-C Clinical Development Program - July 15, 2016
- Synergy Pharmaceuticals Announces Acceptance of NDA for Plecanatide, a Novel Uroguanylin Analog, in Chronic Idiopathic Constipation - April 19, 2016
- Synergy Pharmaceuticals Files NDA for Plecanatide in Chronic Idiopathic Constipation - January 29, 2016
Rhofade (oxymetazoline hydrochloride) Cream
Company: Allergan, Inc.
Date of Approval: January 19, 2017
Treatment for: Acne Rosacea
Rhofade (oxymetazoline hydrochloride) cream is a potent topical vasoconstrictor for the treatment of persistent facial erythema associated with rosacea.
- Allergan Announces FDA Approval of Rhofade (oxymetazoline hydrochloride) Cream for Facial Erythema Associated with Rosacea - January 19, 2017
- Allergan Announces FDA Acceptance of NDA Filing for Oxymetazoline HCI Cream 1.0% - May 24, 2016
Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets
Company: Teva Pharmaceuticals USA, Inc.
Date of Approval: January 17, 2017
Treatment for: Pain
Vantrela ER (hydrocodone bitartrate) is an abuse deterrent opioid formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
- Teva Receives FDA Approval for Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets Formulated with Proprietary Abuse Deterrence Technology - January 18, 2017
- Teva Gains Recommendation for Approval from FDA Advisory Committees for Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets - June 7, 2016
Arymo ER (morphine sulfate) Extended-Release Tablets
Company: Egalet Corporation
Date of Approval: January 9, 2017
Treatment for: Pain
Arymo ER (morphine sulfate) is an extended-release, abuse-deterrent, opioid analgesic formulation for the management of severe pain.
- FDA Approves Arymo ER (morphine sulfate) Abuse-Deterrent Formulation for the Treatment of Chronic Pain - January 9, 2017
- Egalet Notified that FDA Will Not Meet PDUFA Goal Date for Arymo ER - October 13, 2016
- Egalet Announces FDA Advisory Committees Recommend Approval of Abuse-Deterrent Arymo ER (Morphine Sulfate) - August 4, 2016
- Egalet Announces FDA Acceptance of New Drug Application for Arymo ER (Morphine Sulfate) Extended-Release Tablets - February 29, 2016
- Egalet Submits NDA for Arymo ER (Morphine Sulfate) Extended-Release Tablets - December 15, 2015
Spinraza (nusinersen) Injection
Company: Biogen
Date of Approval: December 23, 2016
Treatment for: Spinal Muscular Atrophy
Spinraza (nusinersen) is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.
- FDA Approves Spinraza (nusinersen) for Spinal Muscular Atrophy - December 23, 2016
- Biogen’s Regulatory Applications for Nusinersen as a Treatment for Spinal Muscular Atrophy Accepted by FDA and EMA - October 28, 2016
- Biogen Completes Rolling Submission of New Drug Application to FDA for Nusinersen as a Treatment for Spinal Muscular Atrophy - September 26, 2016
Rubraca (rucaparib) Tablets
Company: Clovis Oncology, Inc.
Date of Approval: December 19, 2016
Treatment for: Ovarian Cancer
Rubraca (rucaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of advanced mutant BRCA ovarian cancer.
- FDA Grants Accelerated Approval to Rubraca (rucaparib) for Advanced Ovarian Cancer - December 19, 2016
- FDA Accepts Clovis Oncology’s NDA for Rucaparib for Priority Review for the Treatment of Advanced Mutant BRCA Ovarian Cancer - August 23, 2016
Eucrisa (crisaborole) Topical Ointment
Company: Pfizer Inc.
Date of Approval: December 14, 2016
Treatment for: Atopic Dermatitis
Eucrisa (crisaborole) is a novel, non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor indicated for the treatment of mild-to-moderate atopic dermatitis.
- FDA Approves Eucrisa (crisaborole) for Eczema - December 14, 2016
- Anacor Pharmaceuticals Announces FDA Acceptance of NDA for Crisaborole Topical Ointment, 2% for the Treatment of Mild-to-Moderate Atopic Dermatitis - March 22, 2016
- Anacor Pharmaceuticals Submits NDA to the FDA for Crisaborole Topical Ointment, 2% for the Treatment of Mild-to-Moderate Atopic Dermatitis - January 7, 2016
Soliqua (insulin glargine and lixisenatide) Injection - formerly iGlarLixi
Company: Sanofi-Aventis U.S. LLC
Date of Approval: November 21, 2016
Treatment for: Diabetes Type 2
Soliqua 100/33 (insulin glargine and lixisenatide) is fixed-ratio combination of the long-acting human insulin analog insulin glargine (Lantus) and the glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide (Adlyxin), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
- Sanofi Receives FDA Approval of Soliqua 100/33 (insulin glargine and lixisenatide) for the Treatment of Adults with Type 2 Diabetes - November 21, 2016
- Zealand Announces New Timelines for a U.S. FDA Decision on iGlarLixi, the Fixed-Ratio Combination of Lixisenatide (Adlyxin) and Lantus, for the Treatment of Type 2 Diabetes - August 20, 2016
- FDA Advisory Committee Recommends Approval of Sanofi Treatment for Adults With Type 2 Diabetes - May 25, 2016
- FDA Accepts Sanofi NDA for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide - February 22, 2016
- Sanofi Submits NDA for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide - December 23, 2015
Xultophy (insulin degludec and liraglutide) Injection - formerly IDegLira
Company: Novo Nordisk
Date of Approval: November 21, 2016
Treatment for: Diabetes Type 2
Xultophy 100/3.6 (insulin degludec and liraglutide) is a fixed-ratio combination of the long-acting basal insulin analog, insulin degludec (Tresiba), and the a glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Victoza), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
- Novo Nordisk Receives FDA Approval for Xultophy 100/3.6 (insulin degludec and liraglutide injection) for Type 2 Diabetes - November 21, 2016
- FDA Extends Regulatory Review Period for IDegLira by Three Months - September 2, 2016
- IDegLira Receives Positive 16-0 Vote in Favour of Approval from FDA Advisory Committee - May 24, 2016
Intrarosa (prasterone) Vaginal Inserts
Company: Endoceutics Inc.
Date of Approval: November 17, 2016
Treatment for: Dyspareunia
Intrarosa (prasterone) is a once-daily, vaginally administered steroid indicated to treat postmenopausal women experiencing moderate to severe pain during sexual intercourse (dyspareunia) as a symptom of vulvar and vaginal atrophy.
- FDA Approves Intrarosa (prasterone) for Postmenopausal Women Experiencing Dyspareunia - November 17, 2016
Vemlidy (tenofovir alafenamide) Tablets
Company: Gilead Sciences, Inc.
Date of Approval: November 10, 2016
Treatment for: Chronic Hepatitis B
Vemlidy (tenofovir alafenamide) is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.
- FDA Approves Gilead’s Vemlidy (tenofovir alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection - November 10, 2016
- Gilead Submits New Drug Application to U.S. FDA for Tenofovir Alafenamide (TAF) for the Treatment of Chronic Hepatitis B - January 12, 2016
Zinplava (bezlotoxumab) Injection
Company: Merck & Co., Inc.
Date of Approval: October 21, 2016
Treatment for: Prevention of Clostridium Difficile Infection Recurrence
Zinplava (bezlotoxumab) is a selective, fully-human, monoclonal antibody that binds to Clostridium difficile toxin B, indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older.
- FDA Approves Merck’s Zinplava (bezlotoxumab) to Reduce Recurrence of Clostridium difficile Infection - October 21, 2016
- Merck Provides Regulatory Update on Biologics Licensing Application for Investigational Agent Bezlotoxumab - July 21, 2016
- Merck Statement on FDA Advisory Committee Meeting for Zinplava (bezlotoxumab), an Investigational Agent for Prevention of Clostridium difficile Infection Recurrence - June 9, 2016
Lartruvo (olaratumab) Injection
Company: Eli Lilly and Company
Date of Approval: October 19, 2016
Treatment for: Soft Tissue Sarcoma
Lartruvo (olaratumab) is a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody indicated in combination with doxorubicin for the treatment of patients with advanced soft tissue sarcoma (STS).
- FDA Grants Accelerated Approval to Lartruvo (olaratumab) for Advanced Soft Tissue Sarcoma - October 19, 2016
- FDA Grants Priority Review For Lilly's Olaratumab, An Investigational Medicine For Advanced Soft Tissue Sarcoma - May 4, 2016
Carnexiv (carbamazepine) Injection
Company: Lundbeck Inc.
Date of Approval: October 7, 2016
Treatment for: Seizures
Carnexiv (carbamazepine) is an intravenous injection formulation of the antiepileptic drug carbamazepine indicated as short-term replacement therapy for oral carbamazepine when oral administration is temporarily not feasible.
- FDA Approves Carnexiv (carbamazepine) injection as Intravenous Short-Term Replacement Therapy for Certain Seizure Types - October 7, 2016
- FDA Accepts Lundbeck Resubmission of New Drug Application for Carnexiv (carbamazepine) - April 22, 2016
Amjevita (adalimumab-atto) Injection - 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 an anti-TNF-α monoclonal antibody biosimilar to Humira, 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) Injection
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
