Discovery Labs has been dealt another blow in its quest to gain approval for Surfaxin, a treatment for premature infant respiratory distress syndrome. The FDA issued an Approvable Letter yesterday, saying that it needed more information on the drug before it could be approved. Discovery says it will review the letter and discuss its next steps with the FDA. The company did not provide details regarding what additional information the FDA is seeking. This is the third approvable letter issued for the drug.
- here's the release [1]
Related Articles:
Discovery Labs to raise $25M [2]
Discovery Labs to explore "strategic alternatives" [3]
Discovery Labs pulls marketing app for Surfaxin [4]
Discovery Labs shares sink on data demand [5]
Links:
[1] http://www.fiercebiotech.com/press-releases/discovery-labs-receives-approvable-letter-fda-surfaxin-rds
[2] http://www.fiercebiotech.com/story/discovery-labs-raise-25m/2007-12-07
[3] http://www.fiercebiotech.com/story/discovery-labs-to-explore-strategic-alternatives/2006-06-20
[4] http://www.fiercebiotech.com/story/discovery-labs-pulls-marketing-app-for-surfaxin/2006-06-07
[5] http://www.fiercebiotech.com/story/discovery-labs-shares-sink-on-data-demand/2006-04-05