Complete Response Letter for GA Depot to treat multiple sclerosis
Viatris Inc. has been informed that Mapi Pharma Ltd. has received a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for GA Depot 40 mg from the FDA
The Companies are reviewing the content of the CRL and will be determining the appropriate next steps. The Companies continue to believe in the potential of the product to provide an important new treatment advancement for patients with multiple sclerosis.
The companies sought approval for GA Depot, a long-acting version of glatiramer acetate, which was being studied to be administered as an intramuscular injection given once every four weeks.
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