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News Details

11/12/2025 12:56

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Alembic Pharmaceuticals gets USFDA approval for Generic Eye Infection Treatment

Alembic Pharmaceuticals Ltd announced on Thursday that it has received final approval from the US Food & Drug Administration (USFDA) for its generic version of Loteprednol Etabonate and Tobramycin ophthalmic suspension, a combination medicine used to treat eye infections.

The approval covers Alembic’s Abbreviated New Drug Application (ANDA) for the ophthalmic suspension in 0.5%/0.3% strength, available in 5 mL and 10 mL pack sizes, the company said in a regulatory filing.

Alembic also received a Competitive Generic Therapy (CGT) designation for this product. With the approval, the company will be eligible for 180 days of CGT exclusivity upon commercial launch.