Par Pharmaceutical Receives Final Approval to Market Generic Marinol(R) CIII (Dronabinol...( Par to Begin Shipping Dronabin...)

Par to Begin Shipping Dronabinol Soft Gel Capsules Immediately

WOODCLIFF LAKE, N.J., June 30 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. (NYSE: PRX) 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.

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.

Important information about dronabinol soft gel capsules

Dronabinol is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid, sesame oil or any ingredients in dronabinol capsules. Warn patients not to drive, operate machinery, or engage in hazardous activity until they establish they can tolerate dronabinol and perform such tasks.

Dronabinol should be used with caution in patients with a history of seizure disorder; patients with cardiac disorders; patients with a history of substance abuse (including alcohol abuse or dependence); patients with mania, depression, or schizophrenia (along with careful psy
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