Alembic Pharmaceuticals Secures USFDA Nod for Eye Surgery Drug

Alembic Pharmaceuticals Ltd received final approval from the USFDA for its generic Difluprednate ophthalmic emulsion, used to treat eye inflammation and pain post-surgery. This approval marks a significant step as it matches the therapeutic equivalence of Sandoz Inc's Durezol eye emulsion.

Alembic Pharmaceuticals Ltd has achieved a pivotal milestone by obtaining final approval from the US Food & Drug Administration for its generic version of Difluprednate ophthalmic emulsion.

This medication is notably used to manage inflammation and pain subsequent to ocular surgery. The approval confirms its therapeutic equivalence to Durezol ophthalmic emulsion, a product by Sandoz Inc.

The emulsion not only addresses post-surgical discomfort but is also indicated for endogenous anterior uveitis, thereby broadening its scope of application in ophthalmology.

(With inputs from agencies.)