FDA Approves Amneal's Prednisolone Acetate Ophthalmic Suspension

Prednisolone acetate ophthalmic suspension, USP 1% is a sterile, topical anti-inflammatory agent for ophthalmic use and is indicated for treating steroid-responsive ocular inflammation.

By
mdspire news news staff
June 13, 2025
1 min

Ophthalmology Management

Objective:

To announce the FDA approval of prednisolone acetate ophthalmic suspension, 1% by Amneal Pharmaceuticals.

Approach:

Product Overview: Prednisolone acetate ophthalmic suspension, USP 1% is a sterile, topical anti-inflammatory agent for ophthalmic use.
Indication: It is indicated for treating steroid-responsive ocular inflammation.
Market Launch: The launch of this product is planned for the third quarter of 2025.

Key Findings:

The product references Pred Forte, a trademark of Allergan, Inc.
Common adverse reactions include elevation of intraocular pressure (IOP), possible development of glaucoma, optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.