Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for dronabinol, a generic version of Solvay Pharmaceutical's Marinol(R), 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.
The details can be read here.
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