FDA — authorised 18 February 2014
- Application: NDA203202
- Marketing authorisation holder: LUNDBECK NA LTD
- Local brand name: NORTHERA
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised Droxidopa capsules on 18 February 2014
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 18 February 2014; FDA has authorised it.
LUNDBECK NA LTD holds the US marketing authorisation.