FDA Approves Generic CINV Drug

Officials with Glenmark Pharmaceuticals Inc, USA announced that they have been granted final approval by the FDA for Aprepitant capsules USP, 40 mg, 80 mg, and 125 mg, the generic version of Emend Capsules, of Merck Sharp & Dohme Corporation. Patients undergoing chemotherapy may use Emend, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting.

Glenmark’s current portfolio consists of 127 products authorized for distribution in the US marketplace and 60 new drug applications pending approval with the FDA.

In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio, according to a release from the company.

Reference

Glenmark Pharmaceuticals receives ANDA approval for Aprepitant Capsules USP, 40 mg, 80 mg, and 125 mg [news release]. Mumbai, India. Glenmark Pharmaceuticals website. Accessed October 16, 2017 at http://www.glenmarkpharma.com/sites/default/files/Glenmark-receives-ANDA-approval-for-Aprepitant-Capsules-USP.pdf