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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

DateArticle
May 17, 2019Approval FDA Approves Gattex (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS)
Dec 21, 2012Approval FDA Approves Gattex to Treat Short Bowel Syndrome
Oct 16, 2012FDA Advisory Committee Unanimously Recommends Approval of Gattex (teduglutide) for Adults with Short Bowel Syndrome (SBS)
Oct 12, 2012FDA Posts Briefing Documents for Advisory Committee Meeting Reviewing Gattex (teduglutide) for Adult Short Bowel Syndrome
Aug 21, 2012NPS Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Gattex (teduglutide)
Aug 13, 2012NPS Pharmaceuticals Announces Extension of Action Date for Gattex NDA to December 30, 2012
Jan 31, 2012NPS Pharmaceuticals Announces FDA Acceptance of New Drug Application for Gattex (teduglutide) for the Treatment of Adult Short Bowel Syndrome (SBS)
Dec  1, 2011NPS Pharmaceuticals Completes Submission of New Drug Application for Gattex (teduglutide) in Adult Short Bowel Syndrome (SBS)
Aug 18, 2011NPS Pharmaceuticals Submits Chemistry, Manufacturing and Controls (CMC) Section of New Drug Application for Gattex

Further information

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