The U.S. Food and Drug Administration on Wednesday said it granted a unit of generic-drug giant Viatris Inc. approval of the first generic version of AbbVie Inc.'s blockbuster dry-eye drug Restasis.
The agency said it approved the generic cyclosporine ophthalmic emulsion 0.05% single-use vials from Mylan Pharmaceuticals Inc. to increase tear output in patients whose production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, commonly known as dry eye.
AbbVie earlier Wednesday reported 2021 revenue of $1.29 billion for Restasis, which was part of its roughly $63 billion acquisition of Allergan in 2020.
Mylan is part of Viatris, the company formed by the 2020 merger of Pfizer Inc.'s off-patent drugs business Upjohn with generic drugmaker Mylan NV.
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