Watson announces final FDA approval for generic Prilosec
CORONA, Calif. The Food and Drug Administration gave final approval Monday to Watson Pharmaceuticals for its application for omeprazole delayed-release capsules USP in 10 mg, 20 mg and 40 mg strengths, the company announced Monday.
The drug is a generic equivalent to AstraZeneca’s Prilosec and is for the short-term treatment of active duodenal ulcer. Being the first to file an application for the 40 mg strength, Watson will receive 180-day marketing exclusivity when the product launches in the third quarter of 2008. Watson will only launch the 40 mg strength.
Prilosec had worldwide sales of $1.143 billion in 2007, according to AstraZeneca’s annual report.