Amneal Pharmaceuticals, Inc. announced the US Food and Drug Administration (FDA) has approved the company’s cyclosporine ophthalmic emulsion 0.05%, a sterile, preservative-free formulation supplied in single-use vials. The product is the generic equivalent of cyclosporine ophthalmic emulsion 0.05% (Restasis; Allergan, an AbbVie company), Amneal Pharmaceuticals said in a press release. 

According to the company, cyclosporine ophthalmic emulsion 0.05% is a topical immunomodulator indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with dry eye syndrome. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs, the company noted.

The most common adverse reaction associated with cyclosporine ophthalmic emulsion 0.05% was ocular burning, the company said.