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AMRX - Amneal receives ANDA approval for difluprednate ophthalmic emulsion
Amneal Pharmaceuticals Inc. Class A
Amneal Pharmaceuticals (NYSE:AMRX) has received Abbreviated New Drug Application (ANDA) approval from the FDA for difluprednate ophthalmic emulsion 0.05%, which is the generic version of Durezol and is used in the treatment of inflammation and pain associated with ocular surgery. According to IQVIA, U.S. annual sales for Durezol and its generic equivalents in the 12 months ended September 2021 were ~$103M.