Breast Cancer

AstraZeneca submits supplemental NDA to FDA for Arimidex

Published in Women's Health Weekly, April 4th, 2002

AstraZeneca announced that the submission of a supplemental New Drug Application (sNDA), with the U.S. Food and Drug Administration (FDA) has been completed for Arimidex (anastrozole) for treatment of early breast cancer in postmenopausal women.

The company is requesting Priority Review, having received Fast Track Designation for this submission on December 21, 2001, from the FDA based on data from the ATAC (Arimidex and Tamoxifen, Alone or in Combination) study, the largest breast cancer treatment trial ever conducted. Arimidex is currently approved in the U.S. for use in advanced breast cancer in postmenopausal women. The FDA grants Priority Review status for...

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Source: Women's Health Weekly (2002-04-04)

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