Keywords: USA, FDA, AstraZeneca, Crestor, Regulation
FDA panel reviewer says benefits of AstraZeneca’s Crestor outweigh risks
Article | 14 December 2009
A US Food and Drug Administration medical reviewer has said the benefit of treating additional patients with Anglo-Swedish drug major AstraZeneca’s cholesterol-lowerer Crestor (rosuvastatin) outweigh the drug’s risks, according to press reports. However, the reviewer said additional study is needed to "further define this benefit-risk ratio."
The company reported that the FDA has posted briefing materials in advance of the December 15 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to discuss the supplemental New Drug Application (sNDA) filed by AstraZeneca.. Enjoying this article? To continue reading you need to login, take a FREE trial or subscribe.
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