FDA — authorised 8 March 2004
- Marketing authorisation holder: AMGEN
- Status: approved
🇺🇸 Sensipar in United States
FDA authorised Sensipar on 8 March 2004
Marketing authorisations
FDA — authorised 19 December 2008
- Application: NDA021688
- Marketing authorisation holder: AMGEN
- Indication: Labeling
- Status: approved
FDA — authorised 17 May 2019
- Application: ANDA210570
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
FDA — authorised 14 May 2020
- Application: ANDA206125
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Indication: Labeling
- Status: approved
FDA — authorised 18 May 2020
- Application: ANDA209226
- Marketing authorisation holder: STRIDES PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 8 December 2023
- Application: ANDA211892
- Marketing authorisation holder: ACCORD HLTHCARE
- Indication: Labeling
- Status: approved
Sensipar 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 Sensipar approved in United States?
Yes. FDA authorised it on 8 March 2004; FDA authorised it on 19 December 2008; FDA authorised it on 17 May 2019.
Who is the marketing authorisation holder for Sensipar in United States?
AMGEN holds the US marketing authorisation.