Drug news
FDA accepts BLA for collagenase clostridium histolyticum to treat patients with cellulite.- Endo International
Endo International plc announced that the 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 6 July 2020. The BLA is supported by the results of the RELEASE-1 and RELEASE-2 Phase III studies, as well as a robust clinical and pre-clinical program.
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