Santarus (NASDAQ: SNTS) Caps off Strong Week with Second FDA Approval
Written by Mike Havrilla
Friday, 04 December 2009 16:44
Santarus (NASDAQ: SNTS) capped off a strong week with its second FDA approval announced AH today.
Following approval of Zegerid OTC earlier in the week, the FDA approved the Company's immediate-release omeprazole / sodium bicarbonate / magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole. The NDA for the new prescription tablet product was approved for all indications the company was seeking, including for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease, or GERD. The Agency has not yet approved a trade name for the new product.
Santarus has submitted an NDA supplement requesting approval of a proposed trade name that includes the “ZEGERID” brand name and anticipates that the FDA will complete its review of this NDA supplement within 180 days, at which time the Company plans to launch the product.
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