Surfaxin FDA Approval History
FDA Approved: Yes (Discontinued) (First approved March 6, 2012)
Brand name: Surfaxin
Generic name: lucinactant
Dosage form: Intratracheal Suspension
Company: Discovery Laboratories, Inc.
Treatment for: Respiratory Distress Syndrome
Marketing Status: Discontinued
Surfaxin (lucinactant) is a synthetic, peptide-containing surfactant indicated for the prevention of respiratory distress syndrome (RDS) in premature infants.
Development timeline for Surfaxin
| Date | Article |
|---|
| Mar 6, 2012 | Approval Discovery Labs Announces FDA Approval of Surfaxin (lucinactant) for Prevention of Respiratory Distress Syndrome |
| Oct 12, 2011 | Discovery Labs Notified of PDUFA Date for Surfaxin |
| Sep 6, 2011 | Discovery Labs Submits Surfaxin Complete Response to FDA |
| Feb 1, 2011 | Discovery Labs Provides Expanded Update Regarding Its Program for Surfaxin U.S. Marketing Authorization |
| Jan 10, 2011 | Discovery Labs Provides Update Regarding Its Program for Surfaxin U.S. Marketing Authorization |
| Jun 8, 2010 | Discovery Labs Receives FDA Guidance Regarding Preclinical Program to Gain Surfaxin Approval |
| May 19, 2010 | Discovery Labs Achieves Key Milestone Towards Potential Surfaxin Approval |
| Oct 2, 2009 | Discovery Labs and FDA Establish Path for Potential Surfaxin Approval |
| Sep 11, 2009 | Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for Surfaxin Approval |
| Jul 2, 2009 | Discovery Labs Reports On Surfaxin End of Review Meeting With FDA |
| May 12, 2009 | Discovery Labs and FDA to Meet On June 2, 2009 to Discuss Surfaxin Complete Response Letter |
| Nov 10, 2008 | FDA Establishes Target Action Date of April 17, 2009 for Potential Approval of Discovery Labs' Surfaxin |
| Oct 20, 2008 | Discovery Labs Submits Complete Response to May 2008 FDA Approvable Letter for Surfaxin for RDS |
| Sep 24, 2008 | Discovery Labs Reports Technical Achievements Towards Gaining FDA Approval of Surfaxin |
| Aug 6, 2008 | Discovery Labs Reports Progress in Responding to Surfaxin FDA Approvable Letter |
| Jun 19, 2008 | Discovery Labs and FDA Meet to Clarify Limited Items in Surfaxin
Approvable Letter |
| May 29, 2008 | Discovery Labs and FDA to Meet On June 18, 2008 to Clarify Limited
Items in Surfaxin Approvable Letter |
| May 5, 2008 | Discovery Labs Provides Guidance On FDA Approvable Letter for
Surfaxin for RDS |
| May 2, 2008 | Discovery Labs Receives An Approvable Letter From FDA for Surfaxin
for RDS |
| Nov 16, 2007 | Discovery Labs' Response to Surfaxin Approvable Letter Deemed
Complete by FDA |
| Nov 1, 2007 | Discovery Labs Submits Response to FDA Approvable Letter for
Surfaxin for RDS in Premature Infants |
| Oct 1, 2007 | Surfaxin Process Validation Batches Achieve Stability Milestone to
Enable Filing of Response to FDA Approvable Letter |
| Aug 2, 2007 | Discovery Labs Provides Update On Progress for Surfaxin for RDS |
| Jan 22, 2007 | Discovery Labs and FDA Reach Clarity On Path Towards Surfaxin RDS Approval |
| Sep 28, 2006 | Discovery Labs Updates Progress On Manufacturing Remediation and Surfaxin FDA Regulatory Matters |
| Apr 5, 2006 | Discovery Labs Receives Second Approvable Letter From FDA for Surfaxin for RDS |
| Oct 21, 2005 | FDA Accepts Discovery Labs' Complete Response to Approvable Letter for Surfaxin |
| Aug 19, 2005 | Discovery Labs Provides Update on Status of Response to FDA Approvable Letter for Surfaxin |
| Aug 15, 2005 | Discovery Labs Provides Status of Previously Submitted Response to FDA Approvable Letter for Surfaxin |
| Jul 29, 2005 | Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants |
| Feb 14, 2005 | Discovery Labs Receives Approvable Letter from FDA for Surfaxin for Respiratory Distress Syndrome in Premature Infants |
| Jun 15, 2004 | Discovery Laboratories Announces FDA Acceptance of Surfaxin New Drug Application |
| Apr 14, 2004 | Discovery Laboratories Files New Drug Application with the FDA to Market Surfaxin for the Prevention of Respiratory Distress Syndrome in Premature Infants |
Further information
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