MSN Group receives US FDA approval for Asenapine Sublingual Tablets

Hyderabad, December 19, 2020: MSN Group (MSN) announced that it received final approval for its Abbreviated New Drug Application for Asenapine Sublingual Tablets, in 2.5 mg and 10 mg strengths, a generic for Saphris®, with the US Food and Drug Administration. These strengths will be launched immediately.  Additionally, the 5mg strength received tentative approval. The product will be launched by its marketing partner Breckenridge Pharmaceutical. MSN has over 100 ANDAs, 375 US Active Drug master files and are the World no 1 in US DMF Filings. MSN 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 $239 million during the twelve months ending September 2020. 

Corporate Comm India (CCI Newswire)