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