FDA News

FDA Approves ZYFLO CR(TM) (Zileuton) Extended-Release Tablets for Critical Therapeutics, DEY Marketing Partner for Chronic Treatment of Asthma

(May 31, 2007)-- Dey announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) of its marketing partner, Critical Therapeutics , for ZYFLO CR (zileuton) extended-release tablets. ZYFLO CR offers twice-daily, extended-release dosing. Under a co-promotion agreement executed between the two companies in March 2007, DEY will co-market Critical Therapeutics' ZYFLO CR.

ZYFLO CR and ZYFLO(zileuton tablets) are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO CR and ZYFLO are not indicated for use in the reversal of bronchospasm in acute asthma attacks, but can be continued during acute exacerbations of asthma. Leukotrienes are inflammatory mediators in asthma that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion. ZYFLO CR uses SkyePharma PLC's  proprietary Geomatrix drug delivery technology, which controls the amount and rate of drug released into the body.

"We applaud our marketing partner's success in securing FDA approval of the only twice-daily leukotriene synthesis inhibitor for asthma," said Mel Engle, President and CEO of DEY. "ZYFLO CR(TM) has a unique mechanism of action that, combined with its twice-daily dosing regimen, could fundamentally expand and improve the treatment options available to asthma patients. We are delighted to participate in commercializing Critical Therapeutics' ZYFLO CR, which will continue to expand DEY's presence in asthma and respiratory care."

In March 2007, Critical Therapeutics and DEY entered into an agreement for the co-promotion of ZYFLO CR and ZYFLO, the immediate-release formulation of zileuton. DEY's sales force began promoting ZYFLO on April 30, 2007. Upon the launch of ZYFLO CR, the combined sales forces of the two companies will begin promoting ZYFLO CR to approximately 15,000 allergists, pulmonologists and primary care physicians across the U.S.

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