Is Ketorolac + Phenylephrine approved by the US FDA?

Drugs@FDA lists 2 application product lines for Ketorolac + Phenylephrine, including OMIDRIA (Prescription); KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE (Prescription).

Is Ketorolac + Phenylephrine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ketorolac + Phenylephrine: Omidria.

Active substances

Ketorolac + Phenylephrine

US FDA 2
EMA 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
OMIDRIA	EQ 0.3% BASE;EQ 1% BASE	solution · irrigation	RAYNER SURGICAL	Prescription	30 May 2014
KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE	EQ 0.3% BASE;EQ 1% BASE	solution · irrigation	LUPIN	Prescription	1 Jul 2019

EMA European Union — centrally authorised medicines

Omidria Rayner Surgical (Ireland) Limited · Authorised · authorised 28 Jul 2015 · ATC S01

Therapeutic indication (EMA)

Omidria is indicated in adults for maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.