Glenmark gets final approval from FDA for Omeprazole DR Capsules ANDA

Glenmark Generics Inc. USA, the subsidiary of Glenmark Generics Limited, has been granted final approval for its abbreviated new drug application (ANDA) from the United States Food and Drug Administration (U.S. FDA) for Omeprazole Delayed Release Capsules, their generic version of Prilosec® by AstraZeneca.

Omeprazole DR Capsules are indicated for the short-term treatment of active duodenal ulcer in adults. The approval is for the 10, 20, and 40mg strengths of Omeprazole. According to IMS Health sales data for the 12-month period ending September 2014, Omeprazole garnered annual sales of approximately USD 520 million.

Glenmark's current portfolio consists of 94 products authorised for distribution in the U.S. marketplace and 72 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.