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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 analog 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)

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).

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