Impax Laboratories, Inc, through its generic drug division Global Pharmaceuticals, announced that the US Food and Drug Administration (FDA) granted final approval of the company's Abbreviated New Drug Application (ANDA) for a generic version of Prilosec 40 mg delayed-release capsules. AstraZeneca markets Prilosec for the treatment of duodenal/gastric ulcers and GERD (gastro-esophageal reflux disease).

The company's versions of generic Prilosec (including previously approved and marketed 10 mg and 20 mg capsules) are one of 12 products covered under its strategic alliance entered into in June 2001 with a subsidiary of Teva Pharmaceutical Industries Ltd. Teva began marketing the 40 mg product immediately.

According to Wolters Kluwer Health, US sales of Prilosec 40 mg capsules were approximately $222 million in the 12 months ended November 2008.

Impax Labs is a technology-based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products.