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FDA Approves Strativa Pharmaceuticals' Zuplenz® (ondansetron) Oral Soluble Film
Date:7/2/2010

vomiting can have serious consequences such as exhaustion, dehydration and undernourishment, which can interfere with treatment and healing.

In June 2008, Strativa and MonoSol Rx entered into an exclusive licensing agreement under which Strativa acquired the U.S. commercialization rights to Zuplenz oral soluble film.  Under the terms of the amended agreement, the FDA approval triggered Strativa's payments to MonoSol Rx of a $4.0 million approval milestone and a $2.0 million pre-launch milestone.

Indication and Important Safety Information

Zuplenz is indicated for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.

The concomitant use of apomorphine with ondansetron is contraindicated based upon reports of profound hypotension and loss of consciousness.

Zuplenz is contraindicated for patients known to have hypersensitivity to the drug.

The most common adverse drug reactions (greater than or equal to 5%) reported in clinical trials of patients receiving ondansetron for prevention of nausea and vomiting associated with cancer chemotherapy or concurrent radiotherapy were headache, malaise/fatigue, constipation, diarrhea, and dizziness. In addition, the most common adverse event reported for postoperative nausea and vomiting and occurring at a rate significantly different from placebo was headache.

About Strativa Pharmaceuticals

Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: '/>"/>

SOURCE Strativa Pharmaceuticals
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