Glenmark gets US FDA nod for Aprepitant nausea capsules

The tablets are generic versions of Merck Sharp and Dohme Corporation’s Emend capsules

Glenmark Pharmaceuticals, USA, has received final approval by the United States Food & Drug Administration (US FDA) for Aprepitant capsules USP, 40 mg, 80 mg, and 125 mg, the company said in a regulatory filing.

The tablets are generic versions of Merck Sharp and Dohme Corporation’s Emend capsules, it added.

According to IMS health sales data for the 12 months ended August, Emend Capsules, 40 mg, 80 mg, and 125 mg achieved annual sales of around $64.9 million, Glenmark said.

The company’s current portfolio consists of 127 products authorised for distribution in the US marketplace and 60 abbreviated new drug applications (ANDAs) which are pending approval with the US FDA, it added.