DEXCEL RECEIVES APPROVABLE LETTER FOR OTC OMEPRAZOLE

Perrigo announced that the FDA has issued an approvable letter for Dexcel Pharma Technologies's new drug application (NDA) for 20-mg omeprazole delayed-release tablets. Perrigo will be the exclusive marketer and distributor of this product for the store-brand OTC market in the U.S. once the product has been approved by FDA.

The currently approved 20-mg omeprazole magnesium tablet on the OTC market, Prilosec OTC, is indicated for the treatment of frequent heartburn and had annual sales of approximately $600 million for the 12 months ending in November, Perrigo said, citing data from Information Resources and ACNielsen.

When Dexcel filed its NDA for 20-mg omeprazole tablets with the FDA, it notified AstraZeneca, the NDA holder and patent owner for Prilosec OTC. In May AstraZeneca filed suit alleging patent infringement to prevent Dexcel from proceeding with the commercialization of its product. The litigation is still pending.