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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

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.

Spinraza FDA Approval History

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.

Rubraca FDA Approval History

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.

Eucrisa FDA Approval History

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.

Soliqua FDA Approval History

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.

Xultophy FDA Approval History

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.

Intrarosa FDA Approval History

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.

Vemlidy FDA Approval History

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.

Zinplava FDA Approval History

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).

Lartruvo FDA Approval History

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.

Carnexiv FDA Approval History

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.

Amjevita FDA Approval History

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.

Exondys 51 FDA Approval History

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.

Kyleena FDA Approval History

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.

Yosprala FDA Approval History

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).

Cuvitru FDA Approval History

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.

Lomaira FDA Approval History

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.

Erelzi FDA Approval History

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.

Troxyca ER FDA Approval History

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.

Sustol FDA Approval History
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