Earlier On Monday, Viatris' Mapi Pharma Received An FDA Complete Response Letter Regarding The New Drug Application For GA Depot 40mg, The Companies Are Reviewing The Content Of The CRL And Will Be Determining The Appropriate Next Steps
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Viatris (VTRS) and its partner Mapi Pharma received a Complete Response Letter (CRL) from the FDA for their New Drug Application for GA Depot 40mg. The companies are currently reviewing the CRL to determine their next steps.
March 11, 2024 | 2:55 pm
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Viatris received a Complete Response Letter from the FDA for GA Depot 40mg, a drug developed in partnership with Mapi Pharma.
Receiving a Complete Response Letter from the FDA is generally seen as a negative development for pharmaceutical companies as it indicates that the application for a new drug cannot be approved in its current form. This could potentially delay the drug's entry to the market, affecting Viatris' potential revenue and growth prospects in the short term.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100