Labeling revision for Crestor approved by FDA

Published: 3-Mar-2005

The FDA has approved AstraZeneca's revisions to the prescribing information for its cholesterol-lowering medication, Crestor (rosuvastatin calcium), based on submissions made by AstraZeneca.


The FDA has approved AstraZeneca's revisions to the prescribing information for its cholesterol-lowering medication, Crestor (rosuvastatin calcium), based on submissions made by AstraZeneca.

'Post-marketing data for Crestor has been thoroughly reviewed over the past year and this labeling revision is the result of that analysis,' said David Brennan, president and ceo, AstraZeneca US. 'The revisions that the FDA has approved provide physicians with further clarification on how best to use the drug with their patients. We continue to believe that Crestor is safe and effective when used according to the prescribing information.'

The basis for the agreed revisions to the prescribing labeling for Crestor, which strengthen points contained in the original labeling, include modifications to dosage instruction; recent clinical trial information regarding special populations; and information regarding post-marketing safety experience with the medicine, based upon information from clinical trial and extensive post-marketing data.

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