Par Pharmaceutical Companies, Inc. has received final approval from the US Food and Drug Administration 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 US 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, a company release stated.

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 US. Par and SVC Pharma LP will share profits equally from the sales of the product.

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 psychiatric monitoring); patients taking sedatives, hypnotics, or other psychoactive drugs; and in elderly patients, pregnant patients, nursing mothers, or paediatric patients.

The most common adverse effects probably related to dronabinol are dizziness, euphoria, paranoid reaction, somnolence, abnormal thinking, abdominal pain, nausea and vomiting.