Alembic Pharma receives final US FDA approval for eye inflammation drug

Alembic Pharmaceuticals Ltd on Wednesday said it has received final approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Difluprednate Ophthalmic Emulsion, 0.05%.

The approved ANDA is therapeutically equivalent to the reference listed drug, Durezol Ophthalmic Emulsion, 0.05%, marketed by Sandoz Inc. Difluprednate ophthalmic emulsion is used for the treatment of inflammation and pain associated with ocular surgery and is also indicated for the treatment of endogenous anterior uveitis.

Alembic said the approval adds to its growing US generics portfolio. With this clearance, the company now has a cumulative total of 233 ANDA approvals from the US FDA, comprising 213 final approvals and 20 tentative approvals.

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Following the announcement, shares of Alembic Pharmaceuticals Ltd recovered from an intraday low of ₹744.75 but continued to trade lower. As of 2:22 pm, the stock was down 0.58% at ₹760.10 on the NSE.