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Generic Version of Prilosec Approved

Generic Version of Prilosec Approved

WebMD Health News


Reviewed by Michael W. Smith, MD

Nov. 1, 2002 -- A generic version of the popular heartburn drug Prilosec soon will be available. The FDA has approved Kremers Urban Development Company's (KUDCo) version of the drug omeprazole. It will be available in 10 mg and 20 mg capsules to treat ulcers, reflux disease, and other gastrointestinal conditions.

KUDCo's drug is the first approved generic omeprazole that does not infringe on formulation patents held by AstraZeneca, the makers of Prilosec. KUDCo says it will begin to market the drug as soon as possible.

The FDA assures that a generic drug is as safe and effective as the brand name drug, and that it is manufactured to the same high-quality standards. In addition, the generic drug is identical to the brand name drug in dosage form, strength, route of administration, and most labeled uses.

The FDA also is considering whether to approve an over-the-counter version of Prilosec.

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