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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

Sunosi (solriamfetol)

Company: Jazz Pharmaceuticals plc
Date of Approval: March 20, 2019
Treatment for: Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome

Sunosi (solriamfetol) is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA).

Zulresso (brexanolone) Injection

Company: Sage Therapeutics
Date of Approval: March 19, 2019
Treatment for: Postpartum Depression

Zulresso (brexanolone) is a gamma-aminobutyric acid A (GABAA) receptor positive allosteric modulator indicated for the treatment of postpartum depression (PPD).

Rocklatan (netarsudil and latanoprost) Ophthalmic Solution

Company: Aerie Pharmaceuticals, Inc.
Date of Approval: March 12, 2019
Treatment for: Glaucoma (Open Angle), Intraocular Hypertension

Rocklatan (netarsudil and latanoprost ophthalmic solution) is a fixed dose combination of the Rho kinase inhibitor netarsudil (Rhopressa) and the prostaglandin analog latanoprost (Xalatan) indicated to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Trazimera (trastuzumab-qyyp) for Injection

Company: Pfizer Inc.
Date of Approval: March 11, 2019
Treatment for: Breast Cancer, Gastric Cancer

Trazimera (trastuzumab-qyyp) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Spravato (esketamine) Nasal Spray

Company: Janssen Pharmaceuticals, Inc.
Date of Approval: March 5, 2019
Treatment for: Treatment-Resistant Depression

Spravato (esketamine) is a rapid acting, nasal spray formulation of a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for use in adults with treatment-resistant depression.

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for Subcutaneous Injection

Company: Genentech, Inc.
Date of Approval: February 28, 2019
Treatment for: Breast Cancer

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) is a combination of the approved HER2/neu receptor antagonist trastuzumab (Herceptin) and recombinant human hyaluronidase PH20 (an enzyme that helps to deliver trastuzumab under the skin) indicated for the treatment of HER2-overexpressing breast cancer.

Adhansia XR (methylphenidate hydrochloride) Extended-Release Capsules

Company: Adlon Therapeutics L.P.
Date of Approval: February 27, 2019
Treatment for: Attention-Deficit / Hyperactivity Disorder

Adhansia XR (methylphenidate hydrochloride) is an extended-release capsule formulation of the approved central nervous system (CNS) stimulant methylphenidate indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients six years and older.

Esperoct (turoctocog alfa pegol) Injection

Company: Novo Nordisk
Date of Approval: February 19, 2019
Treatment for: Hemophilia A

Esperoct (turoctocog alfa pegol, N8-GP) is an extended half-life factor VIII molecule for the treatment of adults and children with hemophilia A.

Egaten (triclabendazole) Tablets

Company: Novartis Pharmaceuticals Corporation
Date of Approval: February 13, 2019
Treatment for: Fascioliasis

Egaten (triclabendazole) is a benzimidazole anthelmintic indicated for the treatment of fascioliasis, a neglected tropical disease (NTD) caused by liver flukes Fasciola hepatica and Fasciola gigantica.

Cablivi (caplacizumab-yhdp) Injection

Company: Ablynx NV
Date of Approval: February 6, 2019
Treatment for: Acquired Thrombotic Thrombocytopenic Purpura

Cablivi (caplacizumab-yhdp) is a von Willebrand factor (vWF)-directed antibody fragment indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

Jeuveau (prabotulinumtoxinA-xvfs) Injection

Company: Evolus, Inc.
Date of Approval: February 1, 2019
Treatment for: Glabellar Lines

Jeuveau (prabotulinumtoxinA) is a proprietary 900 kDa purified botulinum toxin type A formulation for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines.

Wixela Inhub (fluticasone propionate and salmeterol) Inhalation Powder

Company: Mylan N.V.
Date of Approval: January 30, 2019
Treatment for: Asthma, Chronic Obstructive Pulmonary Disease

Wixela Inhub (fluticasone propionate and salmeterol) is a corticosteroid and long-acting beta2-adrenergic agonist (LABA) combination indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

Wixela Inhub is the first approved generic version of Advair Diskus.

Gloperba (colchicine) Oral Solution

Company: Romeg Therapeutics, LLC
Date of Approval: January 30, 2019
Treatment for: Gout

Gloperba (colchicine) is an oral solution formulation of the approved drug colchicine indicated for prophylaxis of gout flares in adults.

Tosymra (sumatriptan) Nasal Spray

Company: Dr. Reddy's Laboratories, Inc.
Date of Approval: January 25, 2019
Treatment for: Migraine

Tosymra (sumatriptan) is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults.

Ontruzant (trastuzumab-dttb) for Injection

Company: Samsung Bioepis Co., Ltd.
Date of Approval: January 18, 2019
Treatment for: Breast Cancer, Gastric Cancer

Ontruzant (trastuzumab-dttb) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Ultomiris (ravulizumab-cwvz) Injection

Company: Alexion Pharmaceuticals, Inc.
Date of Approval: December 21, 2018
Treatment for: Paroxysmal Nocturnal Hemoglobinuria

Ultomiris (ravulizumab-cwvz) is a long-acting C5 complement inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Elzonris (tagraxofusp-erzs) Injection

Company: Stemline Therapeutics, Inc.
Date of Approval: December 21, 2018
Treatment for: Blastic Plasmacytoid Dendritic Cell Neoplasm

Elzonris (tagraxofusp-erzs) is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).

ProAir Digihaler (albuterol sulfate) Inhalation Powder

Company: Teva Pharmaceuticals USA, Inc.
Date of Approval: December 21, 2018
Treatment for: Bronchospasm Prophylaxis, Asthma, Chronic Obstructive Pulmonary Disease

ProAir Digihaler (albuterol sulfate) is a beta2-adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease, and the prevention of exercise-induced bronchospasm.

Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine) Suspension for Intramuscular Injection

Company: Merck and Sanofi
Date of Approval: December 21, 2018
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Pertussis Prophylaxis, Poliomyelitis Prophylaxis, Hepatitis B Prophylaxis, Haemophilus influenzae Prophylaxis

Vaxelis is a hexavalent combination vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b in children from 6 weeks through 4 years of age (prior to the 5th birthday).

Inbrija (levodopa) Inhalation Powder

Company: Acorda Therapeutics, Inc.
Date of Approval: December 21, 2018
Treatment for: Parkinson's Disease

Inbrija (levodopa) is an oral inhalation formulation of the approved drug levodopa for the treatment of OFF episodes in people with Parkinson’s disease taking a carbidopa/levodopa regimen.

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