Glenmark gets USFDA nod for Aprepitant capsules
New Delhi: Glenmark Pharmaceuticals 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 & 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 USD 64.9 million, Glenmark said.
The company's current portfolio consists of 127 products authorized for distribution in the US marketplace and 60 abbreviated new drug applications (ANDAs) which are pending approval with the USFDA, it added.
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