Berlex Receives Approvable Letter for Bonefos (Clodronate) for Adjuvant Treatment of Breast Cancer
MONTVILLE, N.J., January 07, 2005 -- Berlex, Inc., a U.S. affiliate of Schering AG, Germany (NYSE: SHR; FSE: SCH), today announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for Bonefos (clodronate), an oral non-amino bisphosphonate intended to reduce the occurrence of bone metastases in the post-surgical (adjuvant) treatment of breast cancer patients.
Berlex plans to request a meeting with the FDA to discuss the information that is needed to obtain approval, and will submit this information as quickly as possible.
"We look forward to the opportunity to meet with the FDA so we can advance the approval process," said Marc Rubin, MD, member of the Schering AG Board of Executive Directors responsible for Development and Oncology.
Berlex, Inc., is committed to developing novel diagnostics and therapeutics that address unmet medical needs.
Berlex develops and markets diagnostic imaging agents, treatments in the areas of female healthcare and oncology, as well as specialized therapeutics for life-threatening and disabling diseases in the fields of the central nervous system and gastroenterology.
Berlex has business operations in New Jersey, California and Washington.
For more information, please visit www.berlex.com.
Posted: January 2005
- Further Trial Data Awaited for Bonefos in the U.S. - May 11, 2005
- Bonefos Accepted for Filing and Granted Priority Review by FDA - September 9, 2004