Jet lag drug hopes hit snag

22 July 2019
aircraft_jet_landing_stock_2019

Vanda Pharmaceuticals (Nasdaq: VNDA) has hit turbulence in its efforts to broaden the label of its sleep-wake disorder drug Hetlioz (tasimelteon).

The USA-based company is attempting to add the indication of jet lag disorder for Hetlioz, which was launched in the USA in 2014 for non-24-hour sleep wake disorder.

The US Food and Drug Administration (FDA) has notified Vanda that, as part of its ongoing review of the company’s supplemental New Drug Application (sNDA), the agency has identified deficiencies that preclude discussion of labeling and postmarketing requirements at this time.

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