IntelGenx Submits Response to CRL from FDA for RIZAPORT® VersaFilm®
18 Octobre 2022 - 2:00PM
IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or
"IntelGenx"), a leader in pharmaceutical films, today announced
that it has responded to the Complete Response Letter (“CRL”) for
its 505(b)(2) New Drug Application (NDA) for RIZAPORT® VersaFilm®
received from the U.S. Food and Drug Administration (“FDA”) in
March 2020.
“We have been encouraged by our interactions
with the FDA and are pleased to submit our response to the CRL,”
commented Dr. Horst G. Zerbe, CEO of IntelGenx. “Based on the
feedback from our Type A meeting, we conducted additional product
testing and believe that this response provides all of the
additional Chemistry, Manufacturing and Controls information that
the FDA required. We are looking forward to continuing to work with
the Agency to make RIZAPORT® VersaFilm® available to acute migraine
patients.”
About IntelGenx
IntelGenx is a leading drug delivery company
focused on the development and manufacturing of pharmaceutical
films.
IntelGenx’s superior film technologies,
including VersaFilm®, DisinteQ™, VetaFilm™ and transdermal
VevaDerm™, allow for next generation pharmaceutical products that
address unmet medical needs. IntelGenx’s innovative product
pipeline offers significant benefits to patients and physicians for
many therapeutic conditions.
IntelGenx's highly skilled team provides
comprehensive pharmaceuticals services to pharmaceutical partners,
including R&D, analytical method development, clinical
monitoring, IP and regulatory services. IntelGenx's
state-of-the-art manufacturing facility offers full service by
providing lab-scale to pilot- and commercial-scale production. For
more information, visit www.intelgenx.com.
Forward-Looking Information and
Statements
This document may contain forward-looking
information about IntelGenx's 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's 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's 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's annual report on Form
10-K, filed with the United States Securities and Exchange
Commission and available at www.sec.gov, and also filed with
Canadian securities regulatory authorities at www.sedar.com.
IntelGenx assumes no obligation to update any such forward-looking
statements.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen KilmerInvestor Relations(647)
872-4849stephen@kilmerlucas.com
Or
Andre Godin, CPA, CAPresident and CFOIntelGenx Corp.(514)
331-7440 ext 203andre@intelgenx.com
Intelgenx Technologies (TSX:IGX)
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