Oral formulation of Allergan's tazarotene rejected by US FDA panel

18 July 2004

Even though it is already marketed as a gel and a cream, an oral form ofAllergan's tazarotene failed to pass muster with a joint panel of two US Food and Drug Administration advisory committees on July 12. The panel voted nine-three, with four abstentions, that the benefits did not outweigh the risks of the drug for treating moderate-to-very-severe psoriasis.

"It works great for some people," said panelist Eric Holmboe of Yale University School of Medicine. But, he added: "it's not very efficient." Dr Holmboe voted against approval.

The panel - a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee - also felt that Allergan had not crafted a detailed risk management plan to minimize pregnancies in those taking the drug. Tazarotene, a retinoid, is known to cause birth defects. There was some indication also that it might accumulate in semen, though the panel said more study was needed to say whether a male patient could pass on the teratogenicity.

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