Dr. Reddy’s Laboratories Ltd. received approval for Elyxyb (celecoxib oral solution 25 mg/mL) from the U.S. Food and Drug Administration for the acute treatment of migraine with or without aura in adults.
While the healthcare industry looks for ways to combat COVID-19, the beat goes on for drug manufacturers to continue developing and seeking marketing approval for medicines to treat many diseases and conditions. Here is a look at some of the most notable U.S. new drug approvals from Jan. 1 through April 17, 2020.
The U.S. Food and Drug Administration granted approval to Seattle Genetics Inc.’s Tukysa tablets in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
The U.S. Food and Drug Administration accepted a New Drug Application and two supplemental NDAs for Genentech’s Xofluza (baloxavir marboxil).
The U.S. Food and Drug Administration has a busy week of possible drug approvals on the regulatory agency’s calendar, including Celgene’s ozanimod for relapsing forms of multiple sclerosis.
Shares of Acacia Pharma skyrocketed in trading after the company announced FDA approval for Barhemsys (amisulpride injection) for the prevention and treatment of postoperative nausea and vomiting (PONV) in adults.
Shares of Pennsylvania-based Baudax Bio were up more than 40 percent after the company announced that the pain medication Anjeso was greenlit by the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration accepted Jazz Pharmaceuticals and Spain-based PharmaMar’s New Drug Application for lurbinectedin under Priority Review.
The U.S. Food and Drug Administration accepted Aquestive Therapeutics’ New Drug Application for Libervant (diazepam) Buccal Film for seizure clusters.
Emeryville, California-based Zogenix announced positive topline data from the company’s Phase III trial of Fintepla (fenfluramine) in Lennox-Gastaut Syndrome.