FDA — authorised 14 December 2012
- Application: NDA200677
- Marketing authorisation holder: RECORDATI RARE
- Local brand name: SIGNIFOR
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA authorised Signifor (pasireotide) on 14 December 2012
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 14 December 2012.
RECORDATI RARE holds the US marketing authorisation.