Hugel Aesthetics resubmits Botulax to FDA for glabellar lines.
Hugel Aesthetics announced that it has resubmitted its Biologics License Application (BLA) to the FDA for Botulax (letibotulinumtoxinA) for Injection for the treatment of moderate to severe glabellar lines.
Hugel Aesthetics announced that it has resubmitted its Biologics License Application (BLA) to the FDA for Botulax (letibotulinumtoxinA) for Injection for the treatment of moderate to severe glabellar lines. The resubmission follows the receipt of a Complete Response Letter (CRL) from the FDA in March 2022, which required additional data to complete the review of the BLA. Deficiencies cited by the FDA in the CRL were primarily associated with chemistry, manufacturing, controls (CMC), and general updates.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.