FDA rejects Public Citizen's petition on AstraZeneca's Crestor
FDA rejects Public Citizen's petition on AstraZeneca's Crestor
WILMINGTON, DEL., March 14, 2005 -- AstraZeneca reported that
the FDA has formally denied Public Citizen's Health Research
Group's (HRG) petition to remove Crestor (rosuvastatin calcium)
from the market. The FDA's rejection of HRG's petition was based on
a thorough analysis of clinical trial safety data and post-
marketing data.
The company says that the response letter from the FDA stated that
all of the available evidence indicates that Crestor does not pose
a risk of muscle toxicity greater than the other approved statins,
and that with respect to renal toxicity, there is no convincing
evidence that Crestor poses a serious risk of renal injury.
Recently the FDA approved revisions to the Crestor prescribing information, which strengthened language around the appropriate use of Crestor. At the same time, the FDA issued a statement confirming that the potential benefits of statins outweigh the potential risks when taken as directed.
Crestor was unanimously recommended for approval by an FDA advisory board in July 2003.
Following is a link to the FDA's response to Public Citizen's petition: http://www.fda.gov/cder/drug/infopage/rosuvastatin/Crestor_CP.pdf
Source: AstraZeneca
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