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FDA Delays Approval of GA Depot 40mg/mL (glatiramer acetate) Monthly Injection for Relapsing Forms of MS

March 11, 2024

The U.S. Food and Drug Administration has declined to approve GA Depot 40mg/mL (glatiramer acetate, Viatris) which is a long-acting injection version of glatiramer acetate (Copaxone®, Teva and Glatopa®, Sandoz). It is designed to be administered as an intramuscular injection once every four weeks for relapsing forms of MS. Viatris received a Complete Response Letter (CRL) from the FDA which means the FDA is requiring more information from Viatris in order for the FDA to consider approval.  

According to a company press release, Viatris will review the content of the CRL and will determine appropriate next steps. 

Copaxone is a registered trademark of Teva 
Glatopa is a registered trademark of Sandoz 

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