Posted by Michael Wonder on 11 Apr 2022
Hugel says FDA’s complete response letter will not affect Letybo approval
11 April 2022 - Hugel said a complete response letter from the U.S. FDA on botulinum toxin Letybo requires supplementary documents, but it would not have a significant impact on the drug approval.
News reports said that Hugel received the FDA’s complete response letter for Letybo (brand name in Korea: Botulax) on 31 March 2022.
