FDA — authorised 11 April 2016
- Application: NDA208573
- Marketing authorisation holder: ABBVIE
- Local brand name: VENCLEXTA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Venclexta in United States
FDA authorised Venclexta on 11 April 2016
Marketing authorisations
FDA
- Application: ANDA214733
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: VENETOCLAX
- Indication: TABLET
- Status: approved
Venclexta 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 Venclexta approved in United States?
Yes. FDA authorised it on 11 April 2016; FDA has authorised it.
Who is the marketing authorisation holder for Venclexta in United States?
ABBVIE holds the US marketing authorisation.