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Bonefos FDA Approval Status

FDA Approved: No
Brand name: Bonefos
Generic name: clodronate
Company: Berlex, Inc.
Treatment for: Breast Cancer, Adjuvant

Bonefos (clodronate) is a non-amino bisphosphonate intended to reduce the occurrence of bone metastases in the post-surgical (adjuvant) treatment of breast cancer patients.

In January 2005, Berlex, Inc. announced the receipt of an Approvable Letter from the U.S. Food and Drug Administration (FDA), advising the company that approval was dependent upon the results of the ongoing National Surgical Adjuvant Breast and Bowel Project (NSABP) B-34 study. While oral Bonefos is approved in 67 countries outside the United States largely for the treatment of tumor-induced osteolysis and hypercalcemia, it remains commerically undeveloped in the United States.

Development timeline for Bonefos

May 11, 2005Further Trial Data Awaited for Bonefos in the U.S.
Jan  7, 2005Berlex Receives Approvable Letter for Bonefos (Clodronate) for Adjuvant Treatment of Breast Cancer
Sep  9, 2004Bonefos Accepted for Filing and Granted Priority Review by FDA

Further information

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