Endo Announces FDA's Acceptance of Original Biologics License Application (BLA) for Collagenase Clostridium Histolyticum (CCH) in Patients with Cellulite
Endo International plc - Ordinary Shares (ENDP)
Last endo international plc - ordinary shares earnings: 2/26 06:00 am
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Source: PR Newswire
DUBLIN, Nov. 19, 2019 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the original Biologics License Application (BLA) for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks. The Prescription Drug User Fee Act (PDUFA), or target action date for the BLA, has been set for July 6, 2020. "We have confidence in and are excited by the promising results of our CCH for cellulite program, which encompasses the largest U.S. clinical trials for the treatment of cellulite in history1," said Paul Campanelli, Endo's Chairman, President and Chief Executive Officer. "Acceptance of our BLA is a significant milestone and we look forward to advancing the next steps to bring this treatment to aesthetic physicians and their patients."The BLA is supported by the results of the RELEASE*-1 and RELEASE-2 Phase 3 studies, as well as a robust clinical and pre-clinical program.
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