UPDATE 1-Discovery Labs to file Surfaxin response in 4 weeks

Wed Sep 24, 2008 10:02am EDT
 
[-] Text [+]

(New throughout)

Sept 24 (Reuters) - Discovery Laboratories Inc (DSCO.O) said it expects to submit a complete response to the U.S. Food and Drug Administration's concerns on its experimental lung drug for infants within the next four weeks.

The company earlier expected to file the response in September.

In May, the biotechnology company had received an "approvable letter" from the FDA for the drug, Surfaxin. Approvable letters generally mean that a company must satisfy certain conditions before the FDA approves its drug.

Discovery Labs said it achieved "technical success" in addressing remaining requirements by the FDA to get marketing approval for Surfaxin, including additional preclinical studies.

Surfaxin treats respiratory distress syndrome, in which prematurely born infants have difficulty breathing. It has orphan drug designation from the FDA -- a status given to therapies being developed for rare conditions.

Shares of the Warrington, Pennsylvania-based company were trading flat at $1.97 in morning trade on Nasdaq. (Reporting by Suzannah Benjamin in Bangalore; Editing by Varsha Tickoo)

 
Kenneth Griffin, Founder, President and CEO, Citadel Investment Group LLC, speaks during the "Financial Recovery: When and How?" panel at the 2009 Milken Institute Global Conference in Beverly Hills, California April 27, 2009. REUTERS/Phil McCarten
Citadel enters the fray

Kenneth Griffin's powerful hedge fund has waded into the case of Goldman Sachs' purloined computer code, suing three of its former employees for setting up Teza Technologies.  Full Article | Full Coverage 

Join the Reuters Consumer Insight Panel and help us get to know you better

Join the Reuters Consumer Insight Panel and help us get to know you better