New Drug Approvals

New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

FDA Approves Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea

March 20 2019

DUBLIN, March 20, 2019 /PRNewswire/ -- Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) approved Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated...

FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression

March 19 2019

March 19, 2019 -- The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA...

FDA Approves Genentech’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Adults With Extensive-Stage Small Cell Lung Cancer

March 18 2019

South San Francisco, CA -- March 18, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab), in combination with carboplatin and...

Allergan Announces FDA Approval of Avycaz (ceftazidime and avibactam) for Pediatric Patients

March 18 2019

DUBLIN, March 18, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for Avycaz (ceftazidime and avibactam),...

FDA Approves Rocklatan (netarsudil and latanoprost ophthalmic solution) for the Reduction of Intraocular Pressure in Open-Angle Glaucoma or Ocular Hypertension

March 12 2019

DURHAM, N.C.--(BUSINESS WIRE)--Mar. 12, 2019-- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie or the Company), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the...

FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Atopic Dermatitis in Adolescents

March 11 2019

CAMBRIDGE, Mass. and TARRYTOWN, N.Y., March 11, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease...