FDA questions switch to Teva's Bupropion

27 April 2008

The US Food and Drug Administration has released a review that questions the bioequivalence of Israeli firm Teva Pharmaceutical's generic anti-depressant bupropion (trade name Budeprion XL 300mg).

Between January 1 and June 30, 2007, the FDA received 85 post-marketing reports in which patients who switched from Wellbutrin XL 300mg to Bupropion experienced an undesirable effect. In 78 of these events a loss of effect was reported, with a number of cases siting an increase in side effects.

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









Company Spotlight