FDA approves Sandoz's generic Prilosec

1/23/2009

ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of AstraZeneca's Prilosec, agency records show.

The FDA approved Novartis generics division Sandoz's delayed-release capsules in the 40-mg strength. The drug is used to treat gastro-esophageal reflux disease and peptic ulcers. Mylan announced Friday that the FDA had approved its generic version as well. Watson, Dr. Reddy?s Labs, Apotex and Impax also make versions of the drug. 

The branded version of the drug had sales of $211 million in the 12 months ending Sept. 30, according to IMS Health. 

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