FDA — authorised 20 November 2008
- Marketing authorisation holder: NOVARTIS PHARMS CORP
- Status: approved
🇺🇸 Promacta in United States
FDA authorised Promacta on 20 November 2008
Marketing authorisations
FDA — authorised 9 March 2017
- Application: NDA207027
- Marketing authorisation holder: NOVARTIS
- Indication: Labeling
- Status: approved
FDA — authorised 29 November 2023
- Application: NDA216774
- Marketing authorisation holder: TEVA PHARMS INC
- Indication: Type 2 - New Active Ingredient
- Status: approved
FDA — authorised 14 January 2026
- Application: ANDA219638
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Status: approved
FDA — authorised 14 January 2026
- Application: ANDA216281
- Marketing authorisation holder: ZYDUS PHARMS
- Status: approved
FDA — authorised 16 March 2026
- Application: ANDA219121
- Marketing authorisation holder: DR REDDYS
- Status: approved
Promacta 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 Promacta approved in United States?
Yes. FDA authorised it on 20 November 2008; FDA authorised it on 9 March 2017; FDA authorised it on 29 November 2023.
Who is the marketing authorisation holder for Promacta in United States?
NOVARTIS PHARMS CORP holds the US marketing authorisation.