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Business EconomyPosted at: Mar 7 2021 3:51PM


MSN Group receives US FDA approval for its Asenapine Sublingual 5 mg tablets

Hyderabad, Mar 7 (UNI) MSN Group (MSN) has announced that it received final approval for its Abbreviated New Drug Application for Asenapine Sublingual Tablets, in 5 mg strength, a generic for Saphris, with the US Food and Drug Administration.
MSN previously received final approval for 2.5 mg and 10 mg strengths of the same product, a company release here said on Sunday.
The product will be launched by its marketing partner Breckenridge Pharmaceutical.
MSN has over 100 ANDAs, 375 US Active Drug master files and is the World no 1 in US DMF Filings.
It has nine active pharmaceutical ingredient and five finished dosage facilities in Hyderabad including one in the USA.
Asenapine is indicated for the treatment of patients suffering from Schizophrenia & Bipolar disorder.
As per industry sales data, Asenapine had annual sales of USD 239 million during the 12 months, ending September 2020, the release added.
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