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MrWhy.com » Videos » After FDA Warning, BioDelivery Resumes Manufacturing ONSOLIS |
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After FDA Warning, BioDelivery Resumes Manufacturing ONSOLIS
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After FDA Warning, BioDelivery Resumes Manufacturing ONSOLIS
"BioDelivery Sciences International, Inc. (NASDAQ:BDSI) has resumed manufacturing the pain management drug for adult patients with cancer, or ONSOLIS.ONSOLIS was approved in July 2009, but temporarily shut down production at the Aveva Drug Delivery Systems facility after receiving a warning letter from Emma Singleton, the Florida District Director of the Public Health Service sector of the FDA, in May 2010. Singleton described that the facility violated ""Current Good Manufacturing Practice regulations for Finished Pharmaceuticals,"" during an inspection of the facility in the fall of 2009.Mark A. Sirgo, President and Chief Executive Officer of BDSI stated, ""We are pleased to announce that operations at Aveva and the production of ONSOLIS have resumed on the schedule we previously indicated, We now estimate that ONSOLIS supplies will be available no later than March 2011 to support a commercial launch in Canada. Also, as previously mentioned, there has been sufficient stock of ONSOLIS on hand to support continuing U.S. sales activity without disruption.""BioDelivery Sciences closed 0.68 percent higher on Monday at $2.94."
Video Length: 0
Date Found: November 24, 2010
Date Produced: November 24, 2010
View Count: 0
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