Home Latest Drug News News Blog Biodelivery Resumes Manufacturing Onsolis

On November 23, 2010, BioDelivery Sciences Inc. announced that it would continue manufacturing Onsolis (Buccal fentanyl) at its Aveva Drug Delivery Systems facility after it received a warning letter from the Florida District Director of Public Health in May 2010. The letter stated that the facility violated "current good manufacturing practice regulations for finished pharmaceuticals," during an inspection of the facility in the fall of 2009.

According to a BioDelivery Sciences Inc. press release, "we are pleased to announce that operations at Aveva and the production of ONSOLIS have resumed on the schedule we previously indicated," stated Mark A. Sirgo, President and Chief Executive Officer of BDSI. "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."

Onsolis, which was approved in July 2009, is a breakthrough-pain management drug used to treat cancer patients who are taking regularly scheduled doses of another narcotic drug.

 
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