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AstraZeneca welcomes FDA decision on CRESTOR
Posted on 16/12/2009 in Pharmaceutical Company Product News
AstraZeneca's chief medical officer has welcomed approval from a Food and Drug Administration (FDA) committee regarding its CRESTOR (rosuvastatin calcium) treatment.
Dr Howard Hutchinson made his remarks after the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted in favour of the motion that AstraZeneca has established sufficient benefit to offset risks associated with the drug.
The review was based in the results of the company's Jupiter study and is part of a supplemental new drug application that was submitted by AstraZeneca in April of this year in order to update prescribing information about CRESTOR.
Dr Hutchinson said that the discussion will aid in the company's "ongoing dialogue" with the FDA regarding the request for an indication that supports CRESTOR's use for the prevention of cardiovascular disease in those who are at increased risk of cardiovascular events.
Earlier this month, the company announced that the FDA has approved once-daily SEROQUEL XR (quetiapine fumarate) extended release tablets as an add-on treatment to antidepressants in adults who have major depressive disorder.
