FDA — authorised 11 October 2019
- Application: NDA212268
- Marketing authorisation holder: HISAMITSU
- Local brand name: SECUADO
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
FDA authorised Adjunctive asenapine on 11 October 2019
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 11 October 2019.
HISAMITSU holds the US marketing authorisation.