Par Pharmaceutical (PRX) Receives FDA Approval for Generic Marinol

June 30, 2008 2:22 PM EDT

Par Pharmaceutical Companies, Inc. (NYSE: PRX) has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application for dronabinol, a generic version of Solvay Pharmaceutical's Marinol, a CIII controlled substance. This product is approved to treat nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments and is available in 2.5mg, 5 mg and 10 mg strengths.

Annual U.S. sales of Marinol are approximately $190 million, according to IMS Health data. Par will begin shipping all strengths of dronabinol soft gel capsules to the trade immediately.

Under the terms of a license and distribution agreement with SVC Pharma LP, an affiliate of Rhodes Technologies, Par has the right to market, sell and distribute dronabinol in the U.S. Par and SVC Pharma LP will share profits equally from the sales of the product.

Par Pharmaceutical Companies, Inc. is a holding company that, principally through its wholly owned subsidiary, Par Pharmaceutical, Inc., is in the business of developing, manufacturing and distributing generic and branded drugs in the United States. [SM]

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