FDA — authorised 16 July 1998
- Application: NDA020785
- Marketing authorisation holder: BRISTOL-MYERS
- Local brand name: THALOMID
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Thalomid in United States
FDA authorised Thalomid on 16 July 1998
Marketing authorisations
FDA — authorised 25 May 2006
- Application: NDA021430
- Marketing authorisation holder: CELGENE
- Local brand name: THALOMID
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Thalomid in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Thalomid approved in United States?
Yes. FDA authorised it on 16 July 1998; FDA authorised it on 25 May 2006; FDA has authorised it.
Who is the marketing authorisation holder for Thalomid in United States?
BRISTOL-MYERS holds the US marketing authorisation.