FDA — authorised 21 December 2012
- Marketing authorisation holder: NPS PHARMS INC
- Status: approved
🇺🇸 Gattex Kit in United States
FDA authorised Gattex Kit on 21 December 2012
Marketing authorisations
FDA — authorised 21 December 2012
- Application: NDA203441
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: GATTEX KIT
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
The FDA approved Takeda Pharms USA's Gattex Kit for the indication specified in the labeling. This approval was granted on September 5, 2025, following a standard expedited pathway. The application number for this approval is NDA203441.
Gattex Kit in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Gattex Kit approved in United States?
Yes. FDA authorised it on 21 December 2012; FDA authorised it on 21 December 2012.
Who is the marketing authorisation holder for Gattex Kit in United States?
NPS PHARMS INC holds the US marketing authorisation.