Amneal Pharmaceuticals, Inc. has received Abbreviated New Drug Application (ANDA) approval from the U.S. 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.
“With the approval of difluprednate, a complex ophthalmic suspension product, we continue to shift our portfolio to increasingly complex and more differentiated product areas. The wheel of innovation constantly turns at Amneal, and we see a long runway for our R&D engine,” said Chirag and Chintu Patel, Co-Chief Executive Officers.
According to IQVIA®, U.S. annual sales for Durezol® and its generic equivalents in the 12 months ended September 2021 were approximately $103 million.
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