Alembic Pharmaceuticals gets USFDA nod for generic eye treatment drug

The approval granted by USFDA is for the Abbreviated New Drug Application (ANDA) Difluprednate ophthalmic emulsion of strength 0.05 per cent

Alembic Pharmaceuticals Ltd on Tuesday said it has received final approval from the US health regulator for its generic version of Difluprednate ophthalmic emulsion used to treat eye inflammation and pain due to surgery.

The approval granted by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) Difluprednate ophthalmic emulsion of strength 0.05 per cent, Alembic Pharmaceuticals said in a regulatory filing.

The approved ANDA is therapeutically equivalent to the reference listed drug product, Durezol ophthalmic emulsion, 0.05 per cent, of Sandoz Inc, it added.

Difluprednate ophthalmic emulsion is indicated for the treatment of inflammation and pain associated with ocular surgery and also indicated for the treatment of endogenous anterior uveitis, a type of disorder of the eye.