Amneal Pharmaceuticals Announces FDA Approval of Cyclosporine Ophthalmic Emulsion 0.05% for Dry Eye Syndrome Treatment

Monday, Dec 1, 2025 4:02 pm ET1min read

Amneal Pharmaceuticals has announced US FDA approval of cyclosporine ophthalmic emulsion 0.05%, a generic version of Allergan's RESTASIS. The product is expected to launch in Q1 2026 and has a market value of approximately $2.0 billion annually. The approval highlights Amneal's advanced sterile manufacturing capabilities and expansion in complex ophthalmic therapies.

Amneal Pharmaceuticals Announces FDA Approval of Cyclosporine Ophthalmic Emulsion 0.05% for Dry Eye Syndrome Treatment

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