BioAlliance Pharma gains US FDA approval for Oravig

19-Apr-2010 - USA

BioAlliance Pharma SA announced the approval by the US FDA (food and Drug Administration) of Oravig® (miconazole Lauriad®, known as Loramyc® in Europe) for the treatment of oropharyngeal candidiasis (OPC) in adults. Oravig® is licensed to Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. and will be launched in the course of this second semester. The license agreement signed in July 2007 contemplates a $20 million milestone payment upon FDA approval, additional sales milestones and royalties on sales of the product.

“This is a major achievement and the first time for a French biotech company to gain a US approval. BioAlliance expertise in development and registration at the international level is here properly recognized and rewarded. Following our commercial partnership agreement with Therabel Group for Europe (Loramyc® and Setofilm®), we are very confident in Strativa’s commercialization ability to ensure Oravig® success in the US”, said Dominique Costantini, President and CEO of BioAlliance Pharma.

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