FDA — authorised 30 August 2007
- Marketing authorisation holder: IPSEN PHARMA
- Status: approved
🇺🇸 Somatuline Depot in United States
FDA authorised Somatuline Depot on 30 August 2007
Marketing authorisations
FDA — authorised 21 May 2024
- Application: ANDA217193
- Marketing authorisation holder: INVAGEN PHARMS
- Status: approved
FDA — authorised 11 July 2024
- Application: NDA215395
- Marketing authorisation holder: INVAGEN PHARMS
- Indication: Labeling
- Status: approved
The FDA granted marketing authorisation to INVAGEN PHARMS for Somatuline Depot on 11 July 2024. This approval was based on a standard application pathway. Somatuline Depot is indicated for its approved labelling, although the specific indication is not reported in the available data.
FDA — authorised 11 July 2024
- Application: NDA022074
- Marketing authorisation holder: IPSEN PHARMA
- Indication: Labeling
- Status: approved
The FDA approved Somatuline Depot, a product of Ipsen Pharma, for labeling indication. This approval was granted through the standard expedited pathway. Somatuline Depot is a drug product subject to the FDA's marketing authorization.
Somatuline Depot in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Somatuline Depot approved in United States?
Yes. FDA authorised it on 30 August 2007; FDA authorised it on 21 May 2024; FDA authorised it on 11 July 2024.
Who is the marketing authorisation holder for Somatuline Depot in United States?
IPSEN PHARMA holds the US marketing authorisation.