Breast Cancer

Bonefos accepted for filing and granted priority review by FDA

Published in Medical Letter on the CDC and FDA, October 10th, 2004

Schering AG, Germany (SCH, SHR) announced that Bonefos (clodronate) has been accepted for filing and designated for priority review by the U.S. Food and Drug Administration (FDA).

Berlex Laboratories, Schering's U.S. affiliate, is seeking approval for the use of Bonefos as an adjuvant oral treatment for reducing the occurrence of bone metastases in stage II/III breast cancer patients.

"We are tremendously pleased that the FDA has accepted Bonefos for priority review," said Reinhard von Roemeling, MD, VP Clinical Development Oncology, Schering AG Group. "This designation recognizes the significant unmet medical need facing women currently living with...

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Source: Medical Letter on the CDC and FDA (2004-10-10)

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