FDA Approves Amneal’s Cyclosporine Ophthalmic Emulsion 0.05% for Dry Eye
December 2, 2025
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1 min
Amneal Pharmaceuticals, Inc. has received FDA approval for its cyclosporine ophthalmic emulsion 0.05%, a preservative-free formulation available in single-use vials. This product serves as a generic equivalent to Allergan's Restasis and is indicated for increasing tear production in patients suffering from dry eye syndrome due to ocular inflammation. Notably, it has not shown benefits in patients already undergoing treatment with topical anti-inflammatory drugs or punctal plugs. The primary side effect reported is ocular burning.
1. FDA approved Amneal Pharmaceuticals' cyclosporine ophthalmic emulsion 0.05%. 2. Product is preservative-free and in single-use vials. 3. Indicated for dry eye syndrome due to ocular inflammation. 4. Generic equivalent to Allergan's Restasis. 5. Most common side effect is ocular burning.
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