The FDA has approved an abbreviated new drug application for difluprednate ophthalmic emulsion 0.05%, the generic version of Durezol, according to a press release from Amneal Pharmaceuticals.
Difluprednate is used to treat 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,” Chirag Patel and Chintu Patel, co-CEOs of Amneal Pharmaceuticals, said in the release.
Reported adverse events include blepharitis,