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FDA NDA · NDA203441

GATTEX

teduglutide

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA203441
TYPE
NDA
ORIGINAL APPROVAL
2012-12-21
LATEST ACTION
2025-09-05
ROUTE
SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

GATTEX KIT · ReferencePrescription
TEDUGLUTIDE 5MG/VIAL · POWDER · SUBCUTANEOUS

Approval history

2025-09-05Labeling · Supplement 24 · standard — Letter ↗AP
2025-08-13REMS · Supplement 23 — Letter ↗AP
2024-09-19Labeling · Supplement 22 · standard — Label ↗AP
2024-02-21Manufacturing (CMC) · Supplement 21 — Letter ↗AP
2023-01-24Labeling · Supplement 16 · standard — Letter ↗AP
2021-02-11REMS · Supplement 20 — Letter ↗AP
2021-01-29Labeling · Supplement 18 · standard — Label ↗AP
2020-07-14REMS · Supplement 19 — Letter ↗AP
2019-05-16Efficacy · Supplement 13 · priority — Label ↗AP
2018-12-18Efficacy · Supplement 12 · standard — Label ↗AP
2017-03-21REMS · Supplement 10 — Letter ↗AP
2016-05-27REMS · Supplement 8 — Letter ↗AP
2016-03-30Manufacturing (CMC) · Supplement 7 · standardAP
2015-10-05Manufacturing (CMC) · Supplement 6 · standardAP
2015-05-18Manufacturing (CMC) · Supplement 5 · standardAP
2015-01-05Manufacturing (CMC) · Supplement 4 · standardAP
2014-06-26Efficacy · Supplement 2 · standard — Review ↗AP
2012-12-21Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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