FDA — authorised 6 October 2006
- Application: NDA021912
- Marketing authorisation holder: LUPIN
- Local brand name: BROVANA
- Indication: SOLUTION — INHALATION
- Status: approved
FDA authorised Nebulized arformoterol on 6 October 2006
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 6 October 2006; FDA has authorised it.
LUPIN holds the US marketing authorisation.