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Viatris Welcomes FDA Date On Slow-Release Copaxone Product

Collaboration With Mapi Penned In 2018; Firm Plans Filing In Europe

 
• By Dean Rudge

Viatris and Mapi have moved a step closer to realizing the US launch of their 505(b)(2) once- monthly glatiramer acetate product, a follow-on to Teva’s Copaxone treatment for multiple sclerosis.

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• Source: Shutterstock

Viatris and partner Mapi Pharma are set to find out in the first quarter of 2024 whether they can move ahead with their proposed once-monthly glatiramer acetate product, a follow-on to Teva’s Copaxone treatment for multiple sclerosis, after the ‘GA Depot 40mg’ asset was accepted for review by the US Food and Drug Administration.

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