FDA — authorised 30 August 2012
- Marketing authorisation holder: FOREST LABS LLC
- Status: approved
🇺🇸 Linzess in United States
FDA authorised Linzess on 30 August 2012
Marketing authorisations
FDA — authorised 30 August 2012
- Application: NDA202811
- Marketing authorisation holder: ABBVIE
- Local brand name: LINZESS
- Indication: CAPSULE — ORAL
- Status: approved
The FDA approved Linzess, a product of AbbVie, for its efficacy indication on 4 November 2025. This approval was granted through a standard expedited pathway. The application number for this approval is NDA202811.
Linzess 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 Linzess approved in United States?
Yes. FDA authorised it on 30 August 2012; FDA authorised it on 30 August 2012.
Who is the marketing authorisation holder for Linzess in United States?
FOREST LABS LLC holds the US marketing authorisation.