Critical Therapeutics said the FDA has approved the company’s New Drug Application (NDA) for twice-daily Zyflo CR(zileuton) extended-release tablets. Critical Therapeutics, together with its co-promotion partner Dey expect to begin marketing Zyflo CR in the US in the fall of 2007. 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.
Upsher-Smith Laboratories received approval from the FDA for the marketing of Divigel (estradiol gel) 0.1 percent — the lowest approved dose of estradiol available for the treatment of moderate to severe hot flashes associated with menopause.
