Gattex Approval History
FDA Approved: Yes (First approved December 21, 2012)
Brand name: Gattex
Generic name: teduglutide
Dosage form: for Injection
Company: NPS Pharmaceuticals, Inc.
Treatment for: Short Bowel Syndrome
Gattex (teduglutide) is a recombinant analog of human glucagon-like peptide 2 for the treatment of short bowel syndrome in adults and pediatric patients one year of age and older.
Development History and FDA Approval Process for Gattex
|May 17, 2019|| FDA Approves Gattex (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS)|
|Dec 21, 2012|| FDA Approves Gattex to Treat Short Bowel Syndrome|
|Oct 16, 2012||FDA Advisory Committee Unanimously Recommends Approval of Gattex (teduglutide) for Adults with Short Bowel Syndrome (SBS)|
|Oct 12, 2012||FDA Posts Briefing Documents for Advisory Committee Meeting Reviewing Gattex (teduglutide) for Adult Short Bowel Syndrome|
|Aug 21, 2012||NPS Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Gattex (teduglutide)|
|Aug 13, 2012||NPS Pharmaceuticals Announces Extension of Action Date for Gattex NDA to December 30, 2012|
|Jan 31, 2012||NPS Pharmaceuticals Announces FDA Acceptance of New Drug Application for Gattex (teduglutide) for the Treatment of Adult Short Bowel Syndrome (SBS)|
|Dec 1, 2011||NPS Pharmaceuticals Completes Submission of New Drug Application for Gattex (teduglutide) in Adult Short Bowel Syndrome (SBS)|
|Aug 18, 2011||NPS Pharmaceuticals Submits Chemistry, Manufacturing and Controls (CMC) Section of New Drug Application for Gattex|
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