FDA — authorised 1 February 1994
- Application: BLA103411
- Marketing authorisation holder: SIGMA TAU
- Status: supplemented
FDA authorised Oncaspar on 1 February 1994
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 1 February 1994; FDA has authorised it.
SIGMA TAU holds the US marketing authorisation.