Amneal receives FDA nod for generic Durezol

The Food and Drug Administration has given Amneal its blessing for difluprednate ophthalmic emulsion 0.05%.

The product is the generic of Durezol.

[Read more: Amneal intros generic Trisenox]

It 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-CEOs.

[Read more: Amneal launches 1st generic of Intelence]

Durezol and its generics had a market value of roughly $103 million in the 12 months ended September 2021, according to IQVIA.