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8-K Filing
Innoviva (INVA) 8-KRegulation FD Disclosure
Filed: 24 Apr 09, 12:00am
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the |
Date of Report: April 24, 2009 (Date of earliest event reported) | ||||
Theravance, Inc. (Exact name of registrant as specified in its charter) | ||||
Delaware (State or other jurisdiction of incorporation) | 000-30319 (Commission File Number) | 94-3265960 (IRS Employer Identification Number) | ||
901 Gateway Boulevard, South San Francisco, CA (Address of principal executive offices) | 94080 (Zip Code) | |||
650-808-6000 (Registrant's telephone number, including area code) | ||||
Not Applicable (Former Name or Former Address, if changed since last report) |
Item 7.01. Regulation FD Disclosure The information contained in this Item 7.01 and in the accompanying exhibit shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing. On April 24, 2009 Theravance, Inc. announced that the U.S. Food and Drug Administration ("FDA") accepted for review its response to the February 2009 Complete Response letter, which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 16, 2009. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. Item 9.01. Financial Statements and Exhibits (d) 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. |
Dated: April 24, 2009 | THERAVANCE, INC. By: /s/ Michael W. Aguiar |
Exhibit No. | Description |
99.1 | Press Release of Theravance, Inc. dated April 24, 2009 |