US drug major Wyeth says that the Food and Drug Administration has decided to cancel a September 7 meeting of its Psychopharmacologic Drugs Advisory Committee, originally scheduled to examine data in the firm's desvenlafaxine succinate New Drug Application. The drug is intended for use in the treatment of major depressive disorder.
The FDA said that after further consideration of the submitted data it decided that it is no longer necessary to hold the discussion prior to issuing its action letter, expected in October this year. Wyeth said that it was encouraged by the development, adding that it believes the comprehensive clinical trial data it has provided, support the product's approval.
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 accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
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
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze