FDA — authorised 22 July 1969
- Marketing authorisation holder: SIGMA TAU
- Status: approved
🇺🇸 Matulane in United States
FDA authorised Matulane on 22 July 1969
Marketing authorisations
FDA — authorised 22 July 1969
- Application: NDA016785
- Marketing authorisation holder: LEADIANT BIOSCI INC
- Local brand name: MATULANE
- Indication: CAPSULE — ORAL
- Status: approved
Matulane 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 Matulane approved in United States?
Yes. FDA authorised it on 22 July 1969; FDA authorised it on 22 July 1969.
Who is the marketing authorisation holder for Matulane in United States?
SIGMA TAU holds the US marketing authorisation.