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Bonefos accepted for filing and granted priority review by FDA.
2004 OCT 7 - (NewsRx.com & NewsRx.net) -- 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 breast cancer."
The FDA gives priority designation to products that are considered to be a potential significant therapeutic advancement over existing therapies and addresses an unmet medical need. The priority review designation provides for a 6-month review from the date of filing.
A National Cancer Institute (NCI) report estimates that about one in eight women in the United States (approximately 13%) will develop breast cancer during her lifetime. The American Cancer Society estimates that each year nearly 175,000 American women will be diagnosed with breast cancer. 43,300 women will die from breast cancer this year.
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Source: HighBeam Research, Bonefos accepted for filing and granted priority review by FDA.