FDA — authorised 9 August 2021
- Application: ANDA211776
- Marketing authorisation holder: CIPLA
- Local brand name: DIFLUPREDNATE
- Indication: EMULSION — OPHTHALMIC
- Status: approved
🇺🇸 Prednefrin in United States
FDA authorised Prednefrin on 9 August 2021 · 25 US adverse-event reports
Marketing authorisations
FDA — authorised 17 November 2021
- Application: ANDA211526
- Marketing authorisation holder: AMNEAL
- Local brand name: DIFLUPREDNATE
- Indication: EMULSION — OPHTHALMIC
- Status: approved
FDA — authorised 16 November 2022
- Application: ANDA214894
- Marketing authorisation holder: DR REDDYS
- Local brand name: DIFLUPREDNATE
- Indication: EMULSION — OPHTHALMIC
- Status: approved
FDA — authorised 14 May 2024
- Application: ANDA207284
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: DIFLUPREDNATE
- Indication: EMULSION — OPHTHALMIC
- Status: approved
FDA — authorised 13 December 2024
- Application: ANDA219441
- Marketing authorisation holder: CAPLIN
- Local brand name: DIFLUPREDNATE
- Indication: EMULSION — OPHTHALMIC
- Status: approved
FDA — authorised 11 February 2025
- Application: ANDA218191
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: DIFLUPREDNATE
- Indication: EMULSION — OPHTHALMIC
- Status: approved
FDA — authorised 20 March 2025
- Application: ANDA212566
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: DIFLUPREDNATE
- Indication: EMULSION — OPHTHALMIC
- Status: approved
FDA — authorised 26 January 2026
- Application: ANDA213774
- Marketing authorisation holder: ALEMBIC
- Local brand name: DIFLUPREDNATE
- Indication: EMULSION — OPHTHALMIC
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 28 March 2025 – 28 March 2026
- Total reports: 25
Most-reported reactions
- Cystoid Macular Oedema — 4 reports (16%)
- Off Label Use — 4 reports (16%)
- Drug Reaction With Eosinophilia And Systemic Symptoms — 3 reports (12%)
- Accidental Exposure — 2 reports (8%)
- Astigmatism — 2 reports (8%)
- Bone Disorder — 2 reports (8%)
- Developmental Glaucoma — 2 reports (8%)
- Dysaesthesia — 2 reports (8%)
- Hypoaesthesia Oral — 2 reports (8%)
- Impaired Healing — 2 reports (8%)
Other Other approved in United States
Frequently asked questions
Is Prednefrin approved in United States?
Yes. FDA authorised it on 9 August 2021; FDA authorised it on 17 November 2021; FDA authorised it on 16 November 2022.
Who is the marketing authorisation holder for Prednefrin in United States?
CIPLA holds the US marketing authorisation.