Alembic Pharmaceuticals Ltd announced in a press release that it has received final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% (5 mL and 10 mL). According to the company press release, the approved ANDA is therapeutically equivalent to the reference listed drug, Zylet Ophthalmic Suspension, 0.5%/0.3% (Bausch + Lomb).

Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3%, is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists, the company said.

Alembic was granted a competitive generic therapy (CGT) designation for this application. With this approval, Alembic said it is eligible for 180 days of CGT exclusivity upon commercialization.