Amneal Pharmaceuticals Inc. Receives FDA Approval for Prednisolone Acetate Ophthalmic Suspension; Commercial Launch Set for Q3 2025

Reuters
12 Jun
Amneal Pharmaceuticals Inc. Receives FDA Approval for Prednisolone Acetate Ophthalmic Suspension; Commercial Launch Set for Q3 2025

Amneal Pharmaceuticals Inc. has announced that it received approval from the U.S. Food and Drug Administration (FDA) for its prednisolone acetate ophthalmic suspension, 1% sterile, which is a reference to Pred Forte®. This product, designed to treat steroid-responsive ocular inflammation, is part of Amneal's Affordable Medicines segment. The commercial launch is scheduled for the third quarter of 2025. Andy Boyer, Executive Vice President and Chief Commercial Officer of Affordable Medicines, highlighted the approval as a testament to Amneal's R&D capabilities and manufacturing strength. The U.S. market for this product is significant, with annual sales reaching approximately $201 million as of April 2025.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amneal Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9467463-en) on June 12, 2025, and is solely responsible for the information contained therein.

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