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Impax wins final FDA approval for generic ulcer drug

Impax Laboratories, a technology based specialty pharmaceutical company, through its generic drug division Global Pharmaceuticals, has announced that the FDA has granted final approval of its abbreviated new drug application for a generic version of Prilosec 40mg delayed-release capsules.

AstraZeneca markets Prilosec for the treatment of duodenal/gastric ulcers and gastro-esophageal reflux disease.

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