The US Food and Drug Administration yesterday (November 25) lifted some severe limitations on the prescribing of UK pharma giant GlaxoSmithKline’s (LSE: GSK) diabetes drug Avandia (rosiglitazone).
The US regulator said it is requiring the removal of certain restrictions on prescribing and use of Avandia to reflect new information regarding the cardiovascular risk of the medicine. “Today’s actions are consistent with the recommendations of expert advisory committees,” the agency said.
Once blockbuster drug for GSK, Avandia, with sales of over $3 billion in 2006, was approved in 1999 but turnover dropped to miserable $9.5 million last year. However, it is probably too late for the drug to recover its former glory, since its patent expired in 2011.
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