A pivotal bioequivalence study of rizatriptan oral thin-film versus FDA-approved reference product
Phase of Trial: Phase I
Latest Information Update: 05 Dec 2017
At a glance
- Drugs Rizatriptan (Primary)
- Indications Migraine
- Focus Pharmacokinetics; Registrational
- 05 Dec 2017 According to an IntelGenx Corp. media release, a New Drug Application for RIZAPORT was resubmitted to the U.S. FDA in October 2017.
- 13 Apr 2017 According to a RedHill Biopharma media release, RedHill and IntelGenx expect to re-submit the RIZAPORT 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2017.
- 13 Apr 2017 According to a RedHill Biopharma media release, the Ministry of Health of Luxembourg has granted national marketing authorization for RIZAPORT (5 mg and 10 mg), a proprietary oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines. The national marketing authorization was granted in Luxembourg on the basis of the European Decentralized Procedure (DCP), in which Luxembourg served as the Concerned Member State.