MSN Group gets US FDA nod for asenapine sublingual tablets

Our Bureau Hyderabad | Updated on December 15, 2020

MSN Group’s (MSN) marketing partner, Breckenridge Pharmaceutical, has received final approval for its Abbreviated New Drug Application (ANDA) 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 5 mg strength received tentative approval,” Hyderabad-based MSN said in a release.

This product was developed in collaboration with Breckenridge Pharmaceutical for the US Market.

They are indicated for the treatment of patients suffering from schizophrenia and bipolar disorder.

As per industry sales data, Asenapine had annual sales of $239 million during the 12 months ending September 2020.

Published on December 15, 2020

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