Companies

Glenmark gets USFDA nod for Aprepitant nausea capsules

New Delhi | Updated on January 08, 2018 Published on October 16, 2017

Glenmark Pharmaceuticals today said its US-based arm has received final approval from the US FDA for Aprepitant capsules, used for preventing nausea caused by cancer chemotherapy.

Glenmark Pharmaceuticals Inc, USA, has received final approval by the United States Food & Drug Administration (USFDA) 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 USFDA, it added.

Shares of Glenmark Pharmaceuticals rose by 0.63 per cent to Rs 607 in morning trade on BSE.

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Published on October 16, 2017
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