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Kythera Reports FDA Acceptance of ATX-101 NDA, PDUFA Date Set at May 13, 2015

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KYTHERA Biopharmaceuticals, Inc. (Nasdaq: KYTH) today announced that its New Drug Application (NDA) for ATX-101 (deoxycholic acid), has been accepted for filing by the U.S. Food and Drug Administration (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 (PDUFA) 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, 2014.

"We are pleased that KYTHERA's NDA filing has been accepted by the FDA, representing another significant corporate milestone," said Keith Leonard, president and chief executive officer, KYTHERA. "While the area under the chin is important to patients, there are no proven non-surgical options to effectively contour the area under the chin. If approved, ATX-101 will be the first non-surgical treatment for the reduction of submental fat."

Posted-In: News FDA Press Releases


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