MSN gets US FDA nod for Asenapine Sublingual tablets
Hyderabad: MSN Group (MSN) received final approval for its abbreviated new drug application (ANDA) for Asenapine Sublingual Tablets, in 5 mg strength, a generic for Saphris, with the US Food and Drug Administration. Asenapine is indicated for the treatment of patients suffering from Schizophrenia and Bipolar disorder.
MSN previously received final approval for 2.5mg and 10mg strengths of the same product. The product will be launched by its marketing partner Breckenridge Pharmaceutical.
As per industry sales data, Asenapine had annual sales of $239 million during the twelve months ending September 2020.
MSN has over 100 ANDAs and 375 US Active Drug Master Files (DMFs). MSN has nine active pharmaceutical ingredient and five finished dosage facilities in Hyderabad including one in the US.
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