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Article: FDA Advisory Panel Recommends Approval of Zeneca's Nolvadex -Tamoxifen Citrate- for Reduction of Incidence of Breast Cancer in Women At Increased Risk.
- Article from:
- Business Wire
- Article date:
- September 2, 1998
CopyrightCOPYRIGHT 1998 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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WILMINGTON, Del.--(BUSINESS WIRE)--Sept. 2, 1998--Zeneca Pharmaceuticals said that it is encouraged by today's decision by the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) to recommend for approval NOLVADEX(R) (tamoxifen citrate) for reduction of the incidence of breast cancer in women at increased risk, as defined by the National Cancer Institute (NCI) / National Surgical Adjuvant Breast and Bowel Project's (NSABP) Breast Cancer Prevention Trial (BCPT) population. Zeneca believes that this is an appropriate recommendation.
Zeneca filed a Supplemental New Drug Application (sNDA) on April 30, 1998 with the FDA following the ...