Santarus 8-K 2005
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Item 8.01 Other Events.
On July 26, 2005, Santarus, Inc. announced that the U.S. Food and Drug Administration ("FDA") has accepted for filing its New Drug Application ("NDA") for ZEGERID® (omeprazole) Chewable Tablets 40 mg and 20 mg. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Santarus expects the FDA will complete its review or otherwise respond to the ZEGERID Chewable Tablets NDA by March 26, 2006. A press release announcing the acceptance for filing of the NDA is attached to this report as Exhibit 99.1 and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
99.1 -- Press Release dated July 26, 2005
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.