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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.

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