• Most Popular
  • Most Shared

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

Wed Sep 24, 2008 10:02am EDT

Stocks

   

(New throughout)

Stocks  |  Global Markets

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)



More from Reuters

Joint Terminal Attack Controller SSgt Clinton J. Herbison, a U.S. Airman from the 817 Expeditionary Air Support Operations Squadron (EASOS) takes a break during a night mission near Honaker Miracle camp at the Pesh valley of Kunar Province August 12, 2009. Credit: REUTERS/Carlos Barria

Pictures of the Year

A look at the best photos of 2009.  Slideshow 

    The Dalai Lama jokes with a nasal spray after being asked his opinion on the swine flu during a press conference after his first lecture in Lausanne, Switzerland, August 4, 2009. REUTERS/ Valentin Flauraud

    What a wacky year it's been...

    Um, what's up the Dalai Lama's nose? "Oddly Enough" editor Bob Basler rounds up the goofiest photos of the year.  Full Article 

    A caution sign is seen next to a stock board at the Australian Securities Exchange (ASX) in Sydney September 5, 2008. REUTERS/Daniel Munoz
    Political Risk in 2010:

    Don't say we didn't warn you

    With the financial crisis (mostly) in the past, U.S. investors are eying a fresh start to the coming year. Here's a look at what speedbumps lie ahead.  Full Article