Dey LP has announced the FDA’s approval of its New Drug Application (NDA) of its marketing partner, Critical Therapeutics, Inc., for twice-daily extended-release zileuton tablets (Zyflo CR).
Zyflo CR and Zyflo are approved for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zyflo was first approved in 1996 for the treatment of asthma.
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The recommended dose of Zyflo CR is two extended-release 600-mg tablets twice daily within one hour after morning and evening meals (for a total daily dose of 2,400 mg).
The recommended Zyflo dose is one 600-mg immediate-release tablet four times a day (for a total daily dose of 2,400 mg).