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
June 14, 2011
Date of Report (Date of Earliest Event
Reported)
IntelGenx Technologies Corp.
(Exact Name of Registrant as Specified in its Charter)
Delaware | 000-31187 | 87-0638336 |
(State or other jurisdiction of | (Commission File | (IRS Employer Identification |
incorporation) | Number) | No.) |
6425 Abrams, Ville St- Laurent, Quebec, Canada | H4S 1X9 |
(Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code: (514) 331-7440
Check the appropriate box below if the Form 8K fining 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 (17CFR230.425)
[ ] Soliciting material pursuant to Rule
14a-12 under the Exchange Act (17CFR 240.14a -12)
[ ] Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d
-2(b))
[ ] Pre-commencement communication pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e -4(c))
Item 7.01 Regulation FD Disclosure - News Release
IntelGenx Corp. ("IntelGenx", or the Company), announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company's resubmission of its antidepressant CPI-300 New Drug Application 505(b)(2) in response to the February 2010 Complete Response Letter (CRL) as a complete, Class 2 response. In addition, the FDA has established November 13, 2011 as its target action date under the Prescription Drug User Fee Act (PDUFA). CPI-300 is a novel, high strength of Bupropion Hydrochloride (HCl), the active ingredient in Wellbutrin XL®
Exhibit | Description |
99.1 | Press Release |
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.
INTELGENX TECHNOLOGIES CORP.
Dated: June 14,, 2011 | By: /s/ Horst Zerbe |
Horst G.Zerbe | |
President and Chief | |
Executive Officer |