IntelGenx Receives FDA PDUFA Date for RIZAFILM®
IntelGenx Corp. (TSX:IGX) has received FDA acceptance for its Class 2 response to the 2020 Complete Response Letter concerning RIZAFILM® VersaFilm®. The FDA has set a PDUFA goal date of April 17, 2023 for the NDA review. The CEO, Dr. Horst G. Zerbe, expressed optimism about making RIZAFILM® available for acute migraine patients in the U.S.
IntelGenx is known for its innovative pharmaceutical film technologies aimed at addressing unmet medical needs.
- FDA acceptance indicates potential progress for RIZAFILM® NDA.
- PDUFA goal date of April 17, 2023, suggests commitment from FDA.
- CEO's optimism may positively influence investor sentiment.
- None.
SAINT LAURENT, Quebec, Nov. 22, 2022 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, today announced that the U.S. Food and Drug Administration (”FDA”) has accepted for review its Class 2 response to the 2020 Complete Response Letter for its 505(b)(2) New Drug Application (“NDA”) for RIZAFILM® VersaFilm®. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 17, 2023 for completion of the review of the RIZAFILM® NDA.1
“We are pleased to receive confirmation that the FDA is commencing its review of our NDA resubmission, and are looking forward to continuing to work with the Agency to make RIZAFILM® VersaFilm® available to acute migraine patients in the United States,” commented Dr. Horst G. Zerbe, CEO of IntelGenx.
1. RIZAFILM® is a Registered Trademark of Gensco® Pharma Corporation
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 Kilmer
Investor Relations
(647) 872-4849
stephen@kilmerlucas.com
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com
FAQ
What is the significance of the FDA's acceptance of IntelGenx's NDA for RIZAFILM®?
When is the PDUFA goal date for the RIZAFILM® NDA?
What does RIZAFILM® VersaFilm® aim to treat?
Who is the CEO of IntelGenx Corp.?
What is IntelGenx's primary focus in the pharmaceutical sector?
