IntelGenx Receives FDA PDUFA Date for RIZAFILM
IntelGenx Corp., a leader in pharmaceutical films, recently announced the US 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.
“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 US,” said Dr. Horst G. Zerbe, CEO of 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.
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