IntelGenx Announces New PDUFA Date for Its Single Dose 450 mg Bupropion Hydrochloride Tablet
June 14 2011 - 5:00AM
Marketwired
IntelGenx Corp. (TSX VENTURE: IGX)(OTCBB: IGXT) ("IntelGenx", or
"the Company"), announced 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®.
"We are very pleased to note that FDA considers our response to
be complete," said Dr. Horst G. Zerbe, President and Chief
Executive Officer of IntelGenx. "As expected, FDA considers our
resubmission a class 2 response to the CRL and, as such, has issued
a PDUFA target date of 6 months from the date of our resubmission.
We look forward to working with the FDA during the review process
and, following approval, making this proprietary product available
to patients who suffer from major depressive disorder."
About IntelGenx:
IntelGenx is a drug delivery company focused on the development
of oral controlled-release products as well as novel rapidly
disintegrating delivery systems. IntelGenx uses its unique multiple
layer delivery system to provide zero-order release of active drugs
in the gastrointestinal tract. IntelGenx has also developed novel
delivery technologies for the rapid delivery of pharmaceutically
active substances in the oral cavity based on its experience with
rapidly disintegrating films. IntelGenx' research and development
pipeline includes products for the treatment of pain, hypertension,
erectile dysfunction, sleep disorders, allergies and depressive
disorders. More information is available about the company at
www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking information about
IntelGenx' operating results and business prospects that involve
substantial risks and uncertainties. Statements that are not purely
historical are forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended, and
Section 27A of the Securities Act of 1933, as amended. These
statements include, but are not limited to, statements about
IntelGenx' plans, objectives, expectations, strategies, intentions
or other characterizations of future events or circumstances and
are generally identified by the words "may," "expects,"
"anticipates," "intends," "plans," "believes," "seeks,"
"estimates," "could," "would," and similar expressions. All forward
looking statements are expressly qualified in their entirety by
this cautionary statement. Because these forward-looking statements
are subject to a number of risks and uncertainties, IntelGenx'
actual results could differ materially from those expressed or
implied by these forward looking statements. Factors that could
cause or contribute to such differences include, but are not
limited to, those discussed under the heading "Risk Factors" in
IntelGenx' annual report on Form 10-K for the fiscal year ended
December 31, 2010, filed with the United States Securities and
Exchange Commission and available at www.sec.gov, and also filed
with Canadian securities regulatory authorities and www.sedar.com.
IntelGenx assumes no obligation to update any such forward-looking
statements.
Each of the TSX Venture Exchange and OTC Bulletin Board has
neither approved nor disapproved the contents of this press
release.
Contacts: IntelGenx Corp. Dr. Horst G. Zerbe President and CEO
+1 514-331-7440 (ext. 201) +1 514-331-0436 (FAX)
horst@intelgenx.com www.intelgenx.com
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