FDA — authorised 5 June 2024
- Application: ANDA215570
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: PALBOCICLIB
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Palbociclib in United States
FDA authorised Palbociclib on 5 June 2024
Marketing authorisations
FDA
- Application: ANDA213086
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Local brand name: PALBOCICLIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA213089
- Marketing authorisation holder: NATCO PHARMA LTD
- Local brand name: PALBOCICLIB
- Indication: CAPSULE
- Status: approved
FDA
- Application: ANDA213091
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: PALBOCICLIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA214758
- Marketing authorisation holder: MSN PHARMACEUTICALS INC
- Local brand name: PALBOCICLIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA213107
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: PALBOCICLIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA213152
- Marketing authorisation holder: AIZANT DRUG RESEARCH SOLUTIONS PVT LTD
- Local brand name: PALBOCICLIB
- Indication: CAPSULE — ORAL
- Status: approved
Palbociclib 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 Palbociclib approved in United States?
Yes. FDA authorised it on 5 June 2024; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Palbociclib in United States?
ZYDUS LIFESCIENCES holds the US marketing authorisation.