Zegerid
Generic name: omeprazole and sodium bicarbonate
Treatment for: Duodenal Ulcer, GERD, Stomach Ulcer, Erosive Esophagitis
Santarus Announces FDA Action Date of February 27, 2006 for Zegerid Capsules NDA
SAN DIEGO, February 24, 2006 - Santarus, Inc., a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today announced it was informed by the U.S. Food and Drug Administration (FDA) that the action date for response to the New Drug Application (NDA) for Zegerid Capsules under the Prescription Drug User Fee Act (PDUFA) is February 27, 2006, rather than February 26, 2006, as previously communicated by the agency. Therefore, the company anticipates receiving an action letter from the FDA on or about Monday, February 27, 2006.
Posted: February 2006
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Zegerid (omeprazole and sodium bicarbonate) FDA Approval History
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