FDA — authorised 30 May 2014
- Application: NDA205388
- Marketing authorisation holder: RAYNER SURGICAL
- Local brand name: OMIDRIA
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA authorised Phenylephrine-ketorolac on 30 May 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 30 May 2014.
RAYNER SURGICAL holds the US marketing authorisation.