A pivotal bioequivalence study of rizatriptan oral thin-film versus FDA-approved reference product

Trial Profile

A pivotal bioequivalence study of rizatriptan oral thin-film versus FDA-approved reference product

Completed
Phase of Trial: Phase I

Latest Information Update: 13 Apr 2017

At a glance

  • Drugs Rizatriptan (Primary)
  • Indications Migraine
  • Focus Pharmacokinetics; Registrational
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top