Surfaxin Approval History beta

  • FDA approved: Yes (First approved March 6th, 2012)
  • Brand name: Surfaxin
  • Generic name: lucinactant
  • Company: Discovery Laboratories, Inc.
  • Treatment for: Respiratory Distress Syndrome

Surfaxin (lucinactant) is a synthetic, peptide-containing surfactant indicated for the prevention of respiratory distress syndrome (RDS) in premature infants.

FDA Approval History for Surfaxin

DateArticle
Mar  6, 2012Approval Discovery Labs Announces FDA Approval of Surfaxin (lucinactant) for Prevention of Respiratory Distress Syndrome
Oct 12, 2011Discovery Labs Notified of PDUFA Date for Surfaxin
Sep  6, 2011Discovery Labs Submits Surfaxin Complete Response to FDA
Feb  1, 2011Discovery Labs Provides Expanded Update Regarding Its Program for Surfaxin U.S. Marketing Authorization
Jan 10, 2011Discovery Labs Provides Update Regarding Its Program for Surfaxin U.S. Marketing Authorization
Jun  8, 2010Discovery Labs Receives FDA Guidance Regarding Preclinical Program to Gain Surfaxin Approval
May 19, 2010Discovery Labs Achieves Key Milestone Towards Potential Surfaxin Approval
Oct  2, 2009Discovery Labs and FDA Establish Path for Potential Surfaxin Approval
Sep 11, 2009Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for Surfaxin Approval
Jul  2, 2009Discovery Labs Reports On Surfaxin End of Review Meeting With FDA
May 12, 2009Discovery Labs and FDA to Meet On June 2, 2009 to Discuss Surfaxin Complete Response Letter
Nov 10, 2008FDA Establishes Target Action Date of April 17, 2009 for Potential Approval of Discovery Labs' Surfaxin
Oct 20, 2008Discovery Labs Submits Complete Response to May 2008 FDA Approvable Letter for Surfaxin for RDS
Sep 24, 2008Discovery Labs Reports Technical Achievements Towards Gaining FDA Approval of Surfaxin
Aug  6, 2008Discovery Labs Reports Progress in Responding to Surfaxin FDA Approvable Letter
Jun 19, 2008Discovery Labs and FDA Meet to Clarify Limited Items in Surfaxin Approvable Letter
May 29, 2008Discovery Labs and FDA to Meet On June 18, 2008 to Clarify Limited Items in Surfaxin Approvable Letter
May  5, 2008Discovery Labs Provides Guidance On FDA Approvable Letter for Surfaxin for RDS
May  2, 2008Discovery Labs Receives An Approvable Letter From FDA for Surfaxin for RDS
Nov 16, 2007Discovery Labs' Response to Surfaxin Approvable Letter Deemed Complete by FDA
Nov  1, 2007Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants
Oct  1, 2007Surfaxin Process Validation Batches Achieve Stability Milestone to Enable Filing of Response to FDA Approvable Letter
Aug  2, 2007Discovery Labs Provides Update On Progress for Surfaxin for RDS
Jan 22, 2007Discovery Labs and FDA Reach Clarity On Path Towards Surfaxin RDS Approval
Sep 28, 2006Discovery Labs Updates Progress On Manufacturing Remediation and Surfaxin FDA Regulatory Matters
Apr  5, 2006Discovery Labs Receives Second Approvable Letter From FDA for Surfaxin for RDS
Oct 21, 2005FDA Accepts Discovery Labs' Complete Response to Approvable Letter for Surfaxin
Aug 19, 2005Discovery Labs Provides Update on Status of Response to FDA Approvable Letter for Surfaxin
Aug 15, 2005Discovery Labs Provides Status of Previously Submitted Response to FDA Approvable Letter for Surfaxin
Jul 29, 2005Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants
Feb 14, 2005Discovery Labs Receives Approvable Letter from FDA for Surfaxin for Respiratory Distress Syndrome in Premature Infants
Jun 15, 2004Discovery Laboratories Announces FDA Acceptance of Surfaxin New Drug Application
Apr 14, 2004Discovery Laboratories Files New Drug Application with the FDA to Market Surfaxin for the Prevention of Respiratory Distress Syndrome in Premature Infants

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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