New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

Mayzent (siponimod)

Company: Novartis Pharmaceuticals Corporation
Date of Approval: March 26, 2019
Treatment for: Multiple Sclerosis

Mayzent (siponimod) is a sphingosine-1-phosphate receptor modulator for the treatment of secondary progressive multiple sclerosis.

• FDA Approves Mayzent (siponimod) for Secondary Progressive Multiple Sclerosis - March 27, 2019
• Mayzent FDA Approval History

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).

• FDA Approves Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea - March 20, 2019
• Sunosi FDA Approval History

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).

• FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression - March 19, 2019
• Zulresso FDA Approval History

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.

• FDA Approves Rocklatan (netarsudil and latanoprost ophthalmic solution) for the Reduction of Intraocular Pressure in Open-Angle Glaucoma or Ocular Hypertension - March 12, 2019
• Rocklatan FDA Approval History

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.

• FDA Approves Trazimera (trastuzumab-qyyp), a Biosimilar to Herceptin - March 11, 2019
• Trazimera FDA Approval History

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.

• FDA Approves Spravato (esketamine) Nasal Spray for Treatment-Resistant Depression - March 5, 2019
• Spravato FDA Approval History

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.

• FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers - February 28, 2019
• Herceptin Hylecta FDA Approval History

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.

• FDA Approves Adhansia XR (methylphenidate hydrochloride) Extended-Release Capsules for the Treatment of ADHD - March 1, 2019
• Adhansia XR FDA Approval History

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.

• FDA Approves Esperoct (turoctocog alfa pegol, N8-GP) for Hemophilia A - February 19, 2019
• Esperoct FDA Approval History

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.

• FDA Approves Egaten (triclabendazole) for the Treatment of Fascioliasis, a Neglected Tropical Disease - February 13, 2019
• Egaten FDA Approval History

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.

• FDA Approves Cablivi (caplacizumab-yhdp) for Acquired Thrombotic Thrombocytopenic Purpura (aTTP) in Adults - February 6, 2019
• Cablivi FDA Approval History

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.

• FDA Approves Jeuveau (prabotulinumtoxinA-xvfs) for Temporary Improvement in the Appearance of Frown Lines - February 1, 2019
• Jeuveau FDA Approval History

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.

• FDA Approves Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), First Generic of Advair Diskus - January 31, 2019
• Wixela Inhub FDA Approval History

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.

• FDA Approves Gloperba (colchicine) for Prophylaxis of Adult Gout Flares - February 26, 2019
• Gloperba FDA Approval History

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.

• FDA Approves Tosymra (sumatriptan) Nasal Spray for Acute Treatment of Migraine - January 27, 2019
• Tosymra FDA Approval History

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.

• FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin - January 21, 2019
• Ontruzant FDA Approval History

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).

• FDA Approves Ultomiris (ravulizumab-cwvz) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) - December 21, 2018
• Ultomiris FDA Approval History

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).

• FDA Approves Elzonris (tagraxofusp-erzs), the First Treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm and First CD123-Targeted Therapy - December 21, 2018
• Elzonris FDA Approval History

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.

• FDA Approves ProAir Digihaler (albuterol sulfate) as the First and Only Digital Inhaler with Built-In Sensors - December 21, 2018
• ProAir Digihaler FDA Approval History

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).

• FDA Approves Vaxelis Pediatric Hexavalent Combination Vaccine - December 26, 2018
• Vaxelis FDA Approval History