Kythera announces FDA acceptance of ATX-101 NDA

July 10, 2014

Kythera Biopharmaceuticals announced that its New Drug Application, or NDA, for ATX-101, has been accepted for filing by the FDA. The acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review. The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act action date of May 13, 2015. The PDUFA date is the goal date for the FDA to complete its review of the NDA. In addition, the FDA has informed the company that the FDA's Division of Dermatology and Dental Products is currently planning to hold an Advisory Committee meeting on the ATX-101 application during the review. ATX-101 is an injectable treatment currently in late-stage development for the reduction of submental fat, which commonly presents as a double chin. KYTHERA submitted the ATX-101 NDA to the FDA on May 12.