WOODCLIFF LAKE, N.J., June 30 /PRNewswire-FirstCall/ — 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.
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 psychiatric monitoring); patients taking sedatives, hypnotics, or other psychoactive drugs; and in elderly patients, pregnant patients, nursing mothers, or pediatric patients.
The most common adverse effects probably related to dronabinol are dizziness, euphoria, paranoid reaction, somnolence, abnormal thinking, abdominal pain, nausea and vomiting.
Please read full prescribing information available at http://www.parpharm.com/products.
About Par Pharmaceutical
Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit http://www.parpharm.com/.
Safe Harbor Statement
Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward- looking and, as such, are subject to risks and uncertainties, including the extent and impact of litigation arising out of the accounting issues described in the Company’s filings with the Securities and Exchange Commission (SEC), the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against the Company, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company’s filings with the SEC, such as the Company’s reports on Form 10-K, Form 10-Q and Form 8-K, and amendments thereto. Any forward-looking statements included in this press release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.
Par Pharmaceutical Companies, Inc.
CONTACT: Allison Wey, Senior Director, Investor Relations of ParPharmaceutical Companies, Inc., +1-201-802-4000
Web site: http://www.parpharm.com/
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