Posted by Michael Wonder on 27 Sep 2019
IntelGenx announces resubmission of Rizaport new drug application
26 September 2019 - IntelGenx today announced that it has resubmitted its 505(b)(2) new drug application for Rizaport VersaFilm for the treatment of acute migraines to the U.S. FDA.
On 2 April 2019, the Company announced that it had received a complete response letter (CRL) from the FDA regarding the NDA for Rizaport VersaFilm accepted by the Agency on 20 November 2018. The issues cited in the CRL relate to the Chemistry, Manufacturing and Controls section of the application. The FDA requested additional information, but no new bio-equivalence study.
The resubmitted application is subject to the FDA’s acceptance review, the results of which are expected within 30 days.
