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Mylan's Generic Version of Prilosec Approved by FDA

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A generic formulation of Prilosec, from Mylan, has been approved by the U.S. Food and Drug Administration (FDA) for immediate launch.

Prilosec, marketed by AstraZeneca, is used for the treatment of gastric ulcers and gastro-esophageal reflux disease.

Acid reflux or "heartburn" occurs when acid escapes from the stomach and moves up and into the esophagus. The esophagus is not designed to withstand stomach acid.

The new approval is for 40-mg delayed-release capsules. Previously approved versions of Impax’s generic Prilosec, including 10 and 20-mg capsules are one of 12 products included in an alliance which first launched in 2001 with a subsidiary of Teva Pharmaceuticals Industries Ltd.