Hugel Resubmits BLA of Botulax for Glabellar Lines

Seoul, South Korea-based Hugel has resubmitted a Biologics License Application (BLA) for Botulax (botulinum toxin) to the FDA for treatment of frown lines.

The resubmission follows a Complete Response Letter from the agency in March rejecting the initial BLA and citing the need for additional data and improvements in chemistry, manufacturing and controls.

The company has submitted supplemental details and said it now expects to launch the product in the U.S. market in the first half of 2023.