-+ 0.00%
-+ 0.00%
-+ 0.00%

Amneal Pharma Announces FDA Approval For Prednisolone Acetate Ophthalmic Suspension; Product Launch Planned For Q3 2025

Benzinga·06/12/2025 12:10:19
Listen to the news
  • Key complex product approval in the Affordable Medicines segment this year
  • Commercial launch planned for third quarter of 2025

BRIDGEWATER, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. ("Amneal" or the "Company") today announced the U.S. Food and Drug Administration (FDA) approval of prednisolone acetate ophthalmic suspension, 1% sterile which references Pred Forte®. Pred Forte and its design are trademarks of Allergan, Inc., an AbbVie company. Launch of this 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.

According to IQVIA® U.S. annual sales for prednisolone acetate ophthalmic suspension for the 12 months ended April 2025 were approximately $201 million.