Par Pharmaceutical Companies has received final approval from the FDA for its abbreviated new drug application for dronabinol, a generic version of Solvay Pharmaceutical's Marinol, a CIII controlled substance.
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Par’s dronabinol 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, 5mg and 10mg strengths.
Under the terms of a license and distribution agreement with SVC Pharma, an affiliate of Rhodes Technologies, Par has the right to market, sell and distribute dronabinol in the US. Par and SVC Pharma will share profits equally from the sales of the product.
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