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Is Teduglutide legal? FDA status and US regulatory standing
Current status
FDA-approved. Teduglutide is an FDA-approved drug (status recorded ).
Primary source: www.accessdata.fda.gov
Federal legal status
FDA approval status
Teduglutide is an FDA-approved drug. FDA-approved GLP-2 analog. Brand: Gattex (NDA 203441, Dec 2012). Indicated for short bowel syndrome in adults and paediatric patients. Daily subcutaneous injection. Prescription only.
Also known as
Gattex · Revestive · GLP-2 analogue
Status history
- Teduglutide is an FDA-approved drug. [source]
Frequently asked questions
- Is Teduglutide FDA approved?
- Teduglutide is an FDA-approved drug (status recorded 2012-12-21). Primary source linked on this page.
- Can doctors prescribe Teduglutide?
- Teduglutide is listed as prescription-availability in the PeptideBase library. Prescribing rules vary by state and prescriber licensure — consult a licensed clinician.
Content review: Regulatory status is sourced from the linked primary records and reviewed by the PeptideBase editorial team. This page is educational — not legal or medical advice. Last reviewed: .