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Arimidex receives FDA priority review for early breast cancer indication.(Food and Drug Administration )(Brief Article)
2002 JUN 27 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration has granted a 6-month priority review status to the AstraZeneca (AZN) supplemental new drug application (sNDA), which provides data for the use of Arimidex (anastrozole) tablets in the adjuvant treatment of early breast cancer in postmenopausal women.
AstraZeneca filed the sNDA with the FDA for Arimidex on March 4, 2002, having received fast track designation in December of 2001, allowing a rolling submission. Priority review status is granted for new drugs or indications that represent a significant improvement in efficacy or safety over existing treatments.
"AstraZeneca is committed to constantly expanding the treatment options breast cancer patients have at their disposal to fight this disease," said Gerard T. Kennealey, MD, vice president of clinical research, oncology, for AstraZeneca. "The FDA's granting of priority review status for Arimidex as an early breast cancer treatment is ...
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Source: HighBeam Research, Arimidex receives FDA priority review for early breast cancer...