Alembic Pharma Achieves USFDA Approval for Generic Eye Infection Treatment

Alembic Pharmaceuticals Ltd has received approval from the USFDA for its generic ophthalmic suspension, used to treat eye infections. The approval includes Competitive Generic Therapy (CGT) designation, granting 180 days of exclusivity. The generic version is equivalent to Bausch & Lomb's Zylet Ophthalmic Suspension.

Alembic Pharmaceuticals Ltd announced on Thursday that it has secured final approval from the US Food & Drug Administration (USFDA) for its generic version of a popular ophthalmic suspension designed to treat eye infections.

The approval pertains to Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, with available concentrations of 0.5 per cent/0.3 per cent, in both 5 mL and 10 mL sizes. This regulatory approval comes as part of an Abbreviated New Drug Application (ANDA) process.

Achieving a Competitive Generic Therapy (CGT) designation, Alembic Pharmaceuticals now enjoys 180 days of market exclusivity for this product upon its launch. This new drug is therapeutically equivalent to the currently available Zylet Ophthalmic Suspension by Bausch & Lomb Incorporated.

(With inputs from agencies.)