FDAnews
www.fdanews.com/articles/70648-critical-therapeutics-submits-snda-to-fda-for-zyflo

Critical Therapeutics Submits sNDA to FDA for Zyflo

April 4, 2005

Critical Therapeutics has submitted a supplemental new drug application (sNDA) to the FDA for the company's investigational asthma drug Zyflo Filmtab.

Approval of the sNDA would allow Critical Therapeutics to begin marketing its version of Zyflo (zileuton tablets) in the U.S. The FDA approved Zyflo in 1996 for the prevention and chronic treatment of asthma in patients 12 years of age and older.