Women's Health Weekly
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Women's Health Weekly
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Breast Cancer
Further trial data awaited for Bonefos in the U.S.
June 9th, 2005
Berlex, Inc., a U.S. affiliate of Schering, AG, Germany (SCH), announced that the outcome of its new drug application (NDA) for Bonefos (clodronate) is dependent upon the results of the ongoing National Surgical Adjuvant Breast and Bowel Project (NSABP) B-34 study. The decision follows a meeting with the U.S. Food and Drug Administration (FDA) in May at which the agency indicated it would not consider approving Bonefos for marketing until results from the NSABP B-34 trial are known. Final results from the B-34 trial, which completed enrollment of 3323 women with breast cancer in March 2004, are anticipated in 2008. Berlex submitted an NDA for the use...
Source: Women's Health Weekly (2005-06-09)
|
