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news.Critical Therapeutics has submitted a supplemental new drug application to the FDA for the investigational asthma drug Zyflo Filmtab. Approval would allow Critical Therapeutics to begin marketing its version of Zyflo in the US.
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The FDA approved Zyflo in 1996 for the prevention and chronic treatment of asthma in patients 12 years of age and older. Critical Therapeutics in-licensed worldwide rights to Zyflo (zileuton) in March 2004 and to other formulations of zileuton for a range of inflammatory diseases and conditions in December 2003.
Zyflo has been commercially unavailable since early 2004 when commercial supply was depleted. Critical Therapeutics is required to submit a supplemental new drug application (sNDA) for Zyflo because it is changing the manufacturing process and transferring production of the zileuton active pharmaceutical ingredient and the tablet formulation to third-party sites.
“This is an exciting event that moves us one step closer toward our goal of becoming a fully integrated biopharmaceutical company,” said Dr Paul Rubin, president and CEO of Critical Therapeutics. “We anticipate launching Zyflo in the second half of 2005, contingent upon regulatory approval of our sNDA.”