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): June 15, 2006
Encysive Pharmaceuticals Inc.
(Exact name of registrant as specified in its charter)
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| Delaware | | 0-20117 | | 13-3532643 |
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(State or other jurisdiction
of incorporation) | | (Commission
File Number) | | (IRS Employer
Identification No.) |
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4848 Loop Central Drive, Suite 700, Houston, Texas
(Address of principal executive offices) | | 77081
(Zip Code) |
Registrant’s telephone number, including area code:713-796-8822
(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):
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| o | | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| o | | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| o | | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| 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 June 15, 2006, Encysive Pharmaceuticals Inc. (the “Company”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s complete response to the March 24 approvable letter regarding its New Drug Application (NDA) for Thelin™ (sitaxsentan sodium) 100 mg tablets. The FDA has designated the review as a Class 1 resubmission and issued a new Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2006 for the Thelin NDA.
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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.
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| | ENCYSIVE PHARMACEUTICALS INC.
(Registrant)
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| Date: June 15, 2006 | /s/ Paul S. Manierre | |
| | Paul S. Manierre | |
| | Vice President and General Counsel | |
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