FDA approves generic drug for persistent heartburn

In November, the FDA approved the Kremers Urban Development Company's drug application for 10 milligram and 20 milligram omeprazole delayed-release capsules. This approval allows the first marketing of a generic omeprazole product to compete with AstraZeneca LP's Prilosec, which treats persistent heartburn and other symptoms of gastroesophageal reflux disease.

This is not the first approved generic omeprazole, but it is the first approval of a generic omeprazole that does not infringe on patents held by AstraZeneca. The FDA approved the omeprazole application for Andrx Pharmaceuticals, Inc., in November 2001. But Andrx has not been able to market its generic omeprazole because of patent infringement concerns.

Health and Human Services Secretary Tommy G. Thompson says this approval of generic omeprazole represents a win-win situation. Thompson says, "For those who are successfully taking this prescription, it means potential savings, and for those who could not afford the brand-name drug, it means greater access to a successful medication at a lower cost."

Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the brand-name price. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 billion to $10 billion a year at retail pharmacies.

The FDA ensures 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. A generic drug is identical to the brand name drug in dosage form, strength, route of administration, and most labeled uses.

Kremers Urban Development Company is an affiliate of Schwarz Pharma Inc. of Milwaukee.