Viatris announces FDA acceptance of GA Depot NDA
The Fly

Viatris announces FDA acceptance of GA Depot NDA

Viatris and Mapi Pharma announced that the FDA has accepted for review the companies’ recently submitted new drug application, or NDA, for GA Depot 40 mg. The product is a long-acting glatiramer acetate being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis, or RMS. The FDA has assigned a Prescription Drug User Fee Act, or PDUFA, action date of March 8, 2024.

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