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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