RPT-BRIEF-U.S. FDA says approves Aveva's Onsolis for cancer

Thu Jul 16, 2009 12:24pm EDT

 Repeating story with no changes to additional codes
 WASHINGTON, July 16 (Reuters) - The U.S. Food and Drug
Administration:
 * Says approves Onsolis, an opioid pain reliever for
certain cancer patients to manage breakthrough pain.
 * Says Onsolis is made by Aveva and marketed under license
from BioDelivery Sciences International Inc (BDSI.O) by Meda
Pharmaceuticals.
 * Says because Onsolis is in a class of drugs that deliver
fentanyl through mouth's mucous membranes, it was approved with
the requirement of a "risk evaluation and mitigation strategy"
or plan for managing risks with the drug.

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