A pivotal bioequivalence study of rizatriptan oral thin-film versus FDA-approved reference product
Phase of Trial: Phase I
Latest Information Update: 13 Apr 2017
At a glance
- Drugs Rizatriptan (Primary)
- Indications Migraine
- Focus Pharmacokinetics; Registrational
- 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.
- 14 Nov 2016 According to a RedHill Biopharma media release, resubmission of the RIZAPORT NDA to the US FDA is expected in the first half of 2017.