FDA — authorised 8 July 1970
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Status: approved
🇺🇸 Lysodren in United States
FDA authorised Lysodren on 8 July 1970
Marketing authorisations
FDA — authorised 8 July 1970
- Application: NDA016885
- Marketing authorisation holder: ESTEVE
- Local brand name: LYSODREN
- Indication: TABLET — ORAL
- Status: approved
Lysodren 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 Lysodren approved in United States?
Yes. FDA authorised it on 8 July 1970; FDA authorised it on 8 July 1970.
Who is the marketing authorisation holder for Lysodren in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.