Difluprednate ophthalmic emulsion receives FDA approval
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, conjunctival edema, corneal edema, posterior capsule opacification, eye pain, anterior chamber flare and other events associated with Durezol (Novartis).
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