Keywords: USA, FDA, AstraZeneca, Crestor, Cholesterol lowering
US FDA panel gives majority support for broader indication on AstraZeneca’s Crestor
Article | 16 December 2009
As was widely expected following informal comments from a reviewer a few days ago (The Pharma Letter December 14), the US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee has voted 12 yes, four no, and one abstention that AstraZeneca has established sufficient benefit to offset the observed risks to support the use of its blockbuster cholesterol-lowerer Crestor (rosuvastatin calcium) in individuals meeting the following criteria:
* Enjoying this article? To continue reading you need to login, take a FREE trial or subscribe.
FREE unlimited, no obligation access to The Pharma Letter website for 30 days, normally worth £60!
Sign up in less than 60 seconds...no payment needed
Want to read the full article?
Take a 30 day FREE Trial worth £60
Take a no obligations 30 day trial.
Only one trial per user. Find out more details
Subscribe now
for unlimited access to all articles
Subscriptions are £60 per month, pay as you go.
Find out more details.
Already a subscriber? Click here to log in
- Pfizer acts to stop Mylan marketing generic Chantix; Allergan in $600 million settlement over Botox marketing practices
- PDL BioPharma sues Roche’s Genentech over royalties
- Novartis/NIH-sponsored research yields promising malaria drug candidate
- Indian’s Ranbaxy inaugurates new $30 million drug manufacturing facility in South Africa
- Seattle Genetics gets milestone as Astellas unit moves cancer drug into Ph I
