Zegerid

Treatment for Duodenal Ulcer, Gastroesophageal Reflux Disease, Gastric 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.

Source: Santarus, Inc.




Posted: February 2006

Related Articles

Zegerid (omeprazole and sodium bicarbonate) FDA Approval History

View comments

Hide
(web5)