Posted by Michael Wonder on 12 Mar 2024
Viatris and Mapi Pharma statement regarding new drug application for glatiramer acetate depot
11 March 2024 - Viatris has been informed that Mapi Pharma has received a complete response letter regarding the new drug application for glatiramer acetate depot 40 mg from the US FDA.
The Companies are reviewing the content of the complete response letter and will be determining the appropriate next steps.
