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news.Watson Pharmaceuticals has received final approval from the FDA of its abbreviated new drug application for Omeprazole delayed-release capsules USP in the 10mg, 20mg and 40mg strengths.
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Watson has received 180 days of marketing exclusivity for being the first to file an abbreviated new drug application (ANDA) containing a paragraph IV certification for the 40mg strength. Watson’s marketing exclusivity will begin upon commercial launch.
The company plans to launch its Omeprazole delayed-release product during the third quarter of 2008. The specific launch date will depend upon the timing of product validation activities and manufacturing of launch quantities. Watson plans to launch only the 40mg strength.
Omeprazole is the generic equivalent to AstraZeneca’s Prilosec delayed-release capsules USP and is indicated for the short-term treatment of active duodenal ulcer.