January 23, 2015
Westlake Village, Calif., January 23, 2015 – KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today announced the Dermatology and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review KYTHERA’s New Drug Application (NDA) for ATX-101 (deoxycholic acid) for improvement in the appearance of moderate to severe submental fullness in a half-day meeting on the morning of March 9, 2015.
The date and details of the meeting are subject to confirmation by the FDA in a Federal Register notice. KYTHERA submitted the ATX-101 NDA to the FDA on May 12, 2014. The NDA will be subject to a standard review and has a Prescription Drug User Fee Act (PDUFA) action date of May 13, 2015. The PDUFA date is the goal date for the FDA to complete its review of the NDA.
About KYTHERA Biopharmaceuticals, Inc.
KYTHERA Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. KYTHERA’s product candidate, ATX-101, is currently in late-stage clinical development for the treatment of submental fullness, which commonly presents as a double chin, and is a potential first-in-class submental contouring injectable drug. KYTHERA also maintains an active research interest in hair and fat biology, pigmentation modulation and facial contouring. Find more information at www.kytherabiopharma.com.
Director, Investor Relations