The U.S. Food and Drug Administration approved Zogenix Inc.’s Fintepla (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration has a busy two-week period coming up for drug approval reviews.
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.
Emeryville, California-based Zogenix announced positive topline data from the company’s Phase III trial of Fintepla (fenfluramine) in Lennox-Gastaut Syndrome.
Zogenix plans to resubmit a New Drug Application for Fintepla (fenfluramine) to treat seizures associated with Dravet syndrome.
GW Pharmaceuticals’ marijuana-based treatment Epidyolex won a positive recommendation for marketing approval from a European Medicines Agency (EMA) panel for use as an additional treatment for two types of seizures.
Zogenix Inc. intends to resubmit the company’s New Drug Application for Fintepla (ZX008, fenfluramine) for the treatment of seizures associated with Dravet syndrome in third-quarter 2019.
The FDA refused to fully review the marketing application for Zogenix’s treatment for seizures associated with Dravet syndrome.
Over the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler’s diarrhea, migraine headaches and more.
Rockville, Maryland-based Supernus Pharmaceuticals is acquiring Biscayne Neurotherapeutics, which is located in Miami.