Perrigo to Launch Generic Prilosec OTC

After settling with AstraZeneca, Dexcel Pharma Technologies has received final FDA approval for generic Prilosec OTC. The company’s marketing partner Perrigo plans to launch the product early next year.

Perrigo’s announcement came the same day the FDA confirmed there is no evidence of an increased risk of heart problems with Prilosec (omeprazole) or AstraZeneca’s other heartburn drug, Nexium (esomeprazole magnesium).

AstraZeneca sued Dexcel in May 2006 after the company submitted an abbreviated new drug application with Paragraph IV certifications for Prilosec OTC (omeprazole magnesium). As part of the settlement, the companies agreed that Dexcel could market its product as soon as it received final approval. Other terms of the settlement were not disclosed.