Patents
Perrigo Announces Tentative FDA Approval of Dexcel's OTC Omeprazole
Published in Medical Letter on the CDC and FDA, July 8th, 2007
The Perrigo Company (NASDAQ:PRGO) announced that the U.S. Food & Drug Administration (FDA) has granted tentative approval to Dexcel Pharma Technologies, Ltd. (Dexcel) for its new drug application (NDA) for 20 mg omeprazole delayed- release tablets. Once final approval has been granted by the FDA, Perrigo will be the exclusive marketer and distributor of this product for the store brand over-the-counter (OTC) market in the United States.
The reference listed drug (Prilosec OTC(R), Omeprazole delayed-release tablets, 20 mg, AstraZeneca) is subject to a period of patent protection. Dexcel filed its NDA with a paragraph IV patent certification stating that the patents are...
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