- PDUFA Goal Date of March 26, 2020 -
SAINT LAURENT, Quebec, Oct. 22, 2019 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V)(IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, today announced that its 505(b)(2) New Drug Application (“NDA”) for RIZAPORT® VersaFilm® for the treatment of acute migraines has been accepted for review by the U.S. Food and Drug Administration (“FDA”). The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) goal date for completion of the review of the RIZAPORT® NDA of March 26, 2020.
“We are delighted that the FDA has accepted our RIZAPORT® NDA resubmission for review,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “Our team’s tireless work has enabled a timely NDA resubmission that has addressed all of the Agency’s questions, and we are very much looking forward to the FDA’s decision early next year.”
IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.
IntelGenx’s superior film technologies, including VersaFilm®, VetaFilm™ and transdermal, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offer 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 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.
Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Source: IntelGenx Technologies Corp.
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Andre Godin, CPA, CA
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