FDA OK Lifts Critical Therapeutics

Critical Therapeutics(CRTX Quote) bounded 30% Thursday morning after specialty pharmaceutical company Dey announced the Food and Drug Administration had approved a new drug application (NDA) for the asthma treatment Zyflo CR.

The NDA is for twice-daily, extended-release tablets, also known as zileuton. Critical Therapeutics, a Lexington, Mass. biopharmaceutical company, and Dey, which is affiliated with Germany's Merck KGaA, will co-market the drug according to an agreement they made in March.

Zyflo and Zyflo CR are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children age 12 and older, the companies said. ...