Skip to Content

New Drug Approvals Archive - March 2019

See also: New Indications and Dosage Forms for March 2019

March 2019

Spravato (esketamine) Nasal Spray

Date of Approval: March 5, 2019
Company: Janssen Pharmaceuticals, Inc.
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.

Trazimera (trastuzumab-qyyp) for Injection

Date of Approval: March 11, 2019
Company: Pfizer Inc.
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.

Rocklatan (netarsudil and latanoprost) Ophthalmic Solution

Date of Approval: March 12, 2019
Company: Aerie Pharmaceuticals, Inc.
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 F2α analogue latanoprost (Xalatan), indicated to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Zulresso (brexanolone) Injection

Date of Approval: March 19, 2019
Company: Sage Therapeutics
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).

Sunosi (solriamfetol) Tablets

Date of Approval: March 20, 2019
Company: Jazz Pharmaceuticals plc
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).

Mayzent (siponimod) Tablets

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

Mayzent (siponimod) is a sphingosine-1-phosphate receptor modulator for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Jatenzo (testosterone undecanoate) Capsules

Date of Approval: March 27, 2019
Company: Clarus Therapeutics, Inc.
Treatment for: Hypogonadism -- Male

Jatenzo (testosterone undecanoate) is an oral testosterone replacement therapy for the treatment of low testosterone in hypogonadal men.

Mavenclad (cladribine) Tablets

Date of Approval: March 29, 2019
Company: EMD Serono, Inc.
Treatment for: Multiple Sclerosis

Mavenclad (cladribine) is a purine antimetabolite indicated for the treatment of relapsing forms of multiple sclerosis (MS).

Duaklir Pressair (aclidinium bromide and formoterol fumarate) Inhalation Powder

Date of Approval: March 29, 2019
Company: Circassia Pharmaceuticals plc
Treatment for: Chronic Obstructive Pulmonary Disease

Duaklir Pressair (aclidinium bromide and formoterol fumarate) is a long-acting muscarinic antagonist (LAMA) and long-acting beta2 agonist (LABA) fixed dose combination maintenance bronchodilator for the treatment of COPD.

Avaclyr (acyclovir) Ophthalmic Ointment

Date of Approval: March 29, 2019
Company: Fera Pharmaceuticals
Treatment for: Herpes Simplex Dendritic Keratitis

Avaclyr (acyclovir ophthalmic ointment) is a herpes simplex virus nucleoside analog DNA polymerase inhibitor indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus.

New Drug Approvals Archive

More News Resources

Subscribe to our Newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.