FDA accepts NDA for Teva and MedinCell's schizophrenia candidate

1 September 2021
teva-logo-big

Teva Pharmaceutical Industries (NYSE: TEVA) and its partner MedinCell (Euronext: MEDCL) have announced that the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for schizophrenia has been accepted by the US Food and Drug Administration (FDA).

Following the announcement on Tuesday evening, shares in Israeli drugmaker were up 1% in Wednesday’s pre-market trading in New York, while France-based MedinCell was trading 5% higher by lunchtime in Europe.

"NDA file acceptance marks a major milestone for MedinCell"The acceptance is based on Phase III data from two pivotal studies, results from which have not yet been shared. These trials evaluated the efficacy and long-term safety and tolerability of TV-46000 as a treatment for patients with schizophrenia.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical