The U.S. Food and Drug Administration has formally denied Public Citizen�s Health Research Group�s petition to remove AstraZeneca�s cholesterol-lowering statin Crestor� from the market.  The F-D-A�s rejection of the petition was based on a thorough analysis of clinical trial safety data and post-marketing data. President and C-E-O of AstraZeneca U.S., David Brennan:

"The rejection of Public Citizen�s petition by the F-D-A is further proof that CRESTOR� represents an important treatment option for millions of patients who can't get control of their cholesterol."

The response letter from the F-D-A 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.  To date more 18 million prescriptions have been written for the drug.  To learn more about the F-D-A�s denial of the Crestor� petition, visit astrazeneca-dash-us-dot-com.

Crestor� was approved in the U.S. in August 2003 after an F-D-A advisory panel voted unanimously to support its availability.

CRESTOR� is a once-daily prescription medication for use as an adjunct to diet in the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia.  It is a member of the statin class of drug therapy.  CRESTOR� has not been determined to prevent heart disease, heart attacks, or strokes.  For patients with hypercholesterolemia and mixed dyslipidemia, the usual recommended starting dose of CRESTOR� is 10 mg.  Initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive L-D-L-C reductions or who have predisposing factors for myopathy.  For patients with marked hypercholesterolemia and aggressive lipid targets, a 20-mg starting dose may be considered.  AstraZeneca licensed worldwide rights to CRESTOR� from the Japanese pharmaceutical company Shionogi & Co., Ltd. 

Important Safety Information:

CRESTOR� is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases, in women who are pregnant or may become pregnant, and in nursing mothers.  It is recommended that liver function tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically thereafter.  Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria, have been reported with CRESTOR�, and with other drugs in this class.  The 40-mg dose of CRESTOR� is reserved for those patients who have not achieved L-D-L-C goal at 20 mg.  CRESTOR� should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment.  Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.  CRESTOR� is generally well tolerated.  Adverse reactions have usually been mild and transient.  The most frequent adverse events, thought to be related to CRESTOR�, were myalgia, constipation, asthenia, abdominal pain and nausea. A full copy of the prescribing information for CRESTOR� is available at w-w-w-dot-astrazeneca-dash-us-dot-com-forward slash-pi-forward slash-crestor-dot-p-d-f or by calling 1-877-420-7249.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over 21 point four billion dollars and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products.  In the United States, AstraZeneca is a nine point six billion dollar healthcare business with more than 12 thousand employees.  AstraZeneca is listed in the Dow Jones Sustainability Index as well as the F-T-S-E-4-Good Index.  For more information about AstraZeneca, please visit: w-w-w-dot-astrazeneca-dash-u.s.-dot-com.

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