7 November 2014Americas

Glenmark obtains FDA approval for generic omeprazole

Glenmark Generics has been granted approval to market a generic version of AstraZeneca’s ulcer treatment drug Prilosec (omeprazole delayed release capsules).

India-based Glenmark’s US subsidiary Glenmark Generics Inc (GGI) said its Abbreviated New Drug Application (ANDA) was granted final approval by the US Food and Drug Administration (FDA) on Wednesday (November 5).

The capsules are indicated for the short-term treatment of active duodenal ulcers in adults. The FDA approval is for the ten, 20, and 40mg strengths.  The drug has several brand names including Acimax and Omez as well as Prilosec.

Glenmark's current portfolio consists of 94 products authorised for distribution in the US and it has 72 ANDAs awaiting approval.

“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,” the company said in a statement.

According to IMS Health, which provides information for the healthcare industry, Prilosec sales were approximately $520 million in the 12-month period ending September 2014.

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