Alexza Pharmaceuticals 8-K 2012
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 23, 2012 (January 20, 2012)
ALEXZA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Registrants telephone number, including area code: (650) 944-7000
(Former name or former address, if changed since last report.)
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 (see General Instruction A.2. below):
Section 8 Other Events
Item 8.01. Other Events.
On January 23, 2012, Alexza Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of the New Drug Application (NDA) for ADASUVE (Staccato® loxapine). In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) date for the ADASUVE NDA has been extended from February 4, 2012, to May 4, 2012. The press release is furnished as Exhibit 99.1 hereto, the contents of which are incorporated herein by reference.
Section 9 Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
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.
INDEX TO EXHIBITS