Amneal Receives FDA Approval for Prednisolone Acetate Ophthalmic Suspension

Amneal Pharmaceuticals announced the FDA approval of prednisolone acetate ophthalmic suspension 1% sterile, which references Pred Forte (Allergan, an AbbVie company). Launch of the product is planned for the third quarter of 2025.

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.

The most commonly reported adverse reactions for prednisolone acetate ophthalmic suspension in clinical studies were elevation of IOP with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. For prescribing information, see package insert here.