Santarus, Inc.
Santarus Announces Complete Response Letter from FDA on Schering-Plough’s New Drug Application for OTC ZEGERID
Published in Medical Letter on the CDC and FDA, February 1st, 2009
Santarus, Inc. (NASDAQ: SNTS), a specialty pharmaceutical company, announced that Schering-Plough HealthCare Products, Inc. has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) seeking approval to sell a ZEGERID® branded omeprazole/sodium bicarbonate product with the dosage strength of 20 mg of omeprazole in the U.S. over-the-counter (OTC) heartburn market.
The letter outlined questions that the FDA identified during its review of the NDA for OTC ZEGERID. Santarus is in regular communication with Schering-Plough who intends to continue to work closely with the FDA on a confidential basis to...
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