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.
Alembic Pharmaceuticals Gets USFDA Nod For Generic Eye Inflammation Treatment Emulsion
The approved ANDA is therapeutically equivalent to the reference listed drug product, Durezol ophthalmic emulsion, 0.05% of Sandoz Inc, it added
Alembic Pharmaceuticals Gets USFDA Nod For Generic Eye Inflammation Treatment Emulsion Moneycontrol
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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% Alembic Pharmaceuticals said in a regulatory filing.
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.