SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : dsco Discovery Laboratories
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
From: kenhott5/2/2008 7:42:12 AM
   of 318
 
Discovery Labs Receives An Approvable Letter From FDA for Surfaxin for RDS
Friday May 2, 7:00 am ET

WARRINGTON, Pa., May 2, 2008 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (NasdaqGM:DSCO - News) today announced that it has received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. This official notification sets forth the remaining conditions that must be satisfied to gain U.S. marketing approval for Surfaxin.

The Approvable Letter was received in the evening of May 1, 2008, the PDUFA date that had been established for Surfaxin. Prior to receiving this Approvable Letter, Discovery Labs had finalized Surfaxin labeling discussions with the FDA. In addition, the FDA had completed its pre-approval inspection of Discovery Labs' manufacturing facility in Totowa, NJ and recently issued an Establishment Inspection Report (EIR) reflecting a successful inspection.

Discovery Labs is assessing the Approvable Letter and will contact the FDA within the next few days to discuss required actions and timing to gain Surfaxin approval. Discovery Labs expects to be in a position early next week to provide guidance regarding its plans and timeline considerations to address the Approvable Letter.
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2025 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News