Attached files
| file | filename |
|---|---|
| EX-99 - PRESS RELEASE - K-V Pharmaceutical Co | dex99.htm |
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): January 12, 2011
K-V PHARMACEUTICAL COMPANY
(Exact name of registrant as specified in its charter)
Commission File Number 1-9601
| Delaware | 1-9601 | 43-0618919 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| One Corporate Woods Drive Bridgeton, MO | 63044 | |
| (Address of principal executive offices) | (Zip Code) |
(314) 645-6600
(Registrant’s telephone number, including area code)
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. |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act. |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act. |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. |
| Item 8.01 | Other Events. |
On January 12, 2011, K-V Pharmaceutical Company (the “Registrant”) updated the status of the review by the U.S. Food and Drug Administration (the “FDA”) of Hologic, Inc.’s new drug application for Gestiva™ (hydroxyprogesterone caproate injection). Hologic advised the Registrant that the FDA requested additional information on the Gestiva™ application which was provided to the FDA by Hologic on January 10, 2011. In order to provide additional time for the FDA review, the FDA has extended the Prescription Drug User Fee Act action date for the Gestiva™ application to April 13, 2011.
A copy of the press release is attached hereto as Exhibit 99.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | The following exhibit is furnished as part of this report: |
| Exhibit |
Description | |
| 99 | Press Release dated January 12, 2011, issued by K-V Pharmaceutical Company. | |
The Registrant will post this Form 8-K on its Internet website at www.kvpharmaceutical.com. References to the Registrant’s website address are included in this Form 8-K and the press release only as inactive textual references and the Registrant does not intend them to be active links to its website. Information contained on the Registrant’s website does not constitute part of this Form 8-K or the press release.
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SIGNATURES
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.
Dated: January 14, 2011
| K-V PHARMACEUTICAL COMPANY | ||
| By: | /S/ GREGORY J. DIVIS, JR. | |
| Gregory J. Divis, Jr. | ||
| President and Chief Executive Officer | ||