All FDA drug approvals

FDA approval · Drugs@FDA

QWOcollagenase clostridium histolyticum-aaes

BLA761146 ·

FDA approved the original biologics license application for QWO on July 6, 2020, sponsored by ENDO GLOBAL AESTHETICS LTD. FDA’s record shows no approved efficacy supplement on the application since.

Application
BLA761146
Sponsor
ENDO GLOBAL AESTHETICS LTD
Original approval
Review
standard review
Submission class
TYPE 10- BLA
Active ingredient
collagenase clostridium histolyticum-aaes

Products under this application

Ingredient and strengthFormRouteMarketing status
collagenase clostridium histolyticum-aaes 1.84MG/VIALSOLUTIONSUBCUTANEOUSPrescription
collagenase clostridium histolyticum-aaes 0.92MG/VIALSOLUTIONSUBCUTANEOUSPrescription

Approved efficacy supplements

An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.

FDA’s record shows no approved efficacy supplement on this application.

Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.

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