UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 23, 2009
QUESTCOR PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
| | | | | |
| California | | 001-14758 | | 33-0476164 |
(State or Other Jurisdiction
of Incorporation) | | (Commission File Number) | | (I.R.S. Employer
Identification No.) |
| | | | | |
3260 Whipple Road, Union City, California
(Address of Principal Executive Offices) | | | | 94587
(Zip Code) |
Registrant’s telephone number, including area code:(510) 400-0700
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):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
TABLE OF CONTENTS
Item 8.01 Other Events.
On December 23, 2009, Questcor Pharmaceuticals, Inc. (the “Company”) was informed by the U.S. Food & Drug Administration (“FDA”) that the FDA now considers that the Company has provided a complete response to all prior action letters for its supplemental New Drug Application (“sNDA”) to market H.P. Acthar® Gel (repository corticotrophin injection) for the treatment of infantile spasms. The FDA has set the user fee goal date (“PDUFA”) of June 11, 2010 for this sNDA.
A copy of the press release announcing the FDA’s response to the Company is filed as Exhibit 99.1 hereto and incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(c) Exhibits.
| | | |
| Exhibit No. | | Description |
| | | |
| 99.1 | | Questcor Pharmaceuticals, Inc. press release dated December 24, 2009. |
SIGNATURE
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.
| | | | | |
| Date: December 28, 2009 | QUESTCOR PHARMACEUTICALS, INC.
| |
| | By: | /s/ Don Bailey | |
| | | Don Bailey | |
| | | President and Chief Executive Officer
| |
EXHIBIT INDEX
| | | |
| Exhibit No. | | Description |
| | | |
| 99.1 | | Questcor Pharmaceuticals, Inc. press release dated December 24, 2009. |
