Alembic Pharmaceuticals (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, 0.5 per cent / 0.3 per cent, in 5 mL and 10 mL presentations.
The approved ANDA is listed as therapeutically equivalent to the reference listed drug (RLD) Zylet Ophthalmic Suspension, 0.5 per cent / 0.3 per cent, marketed by Bausch & Lomb Incorporated. Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5 per cent / 0.3 per cent, 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 label provides the detailed indication.
Alembic received a Competitive Generic Therapy (CGT) designation for the application. The company is eligible for 180 days of CGT exclusivity upon commercialisation following this approval.
Alembic now has a cumulative total of 231 ANDA approvals from the USFDA, comprising 211 final approvals and 20 tentative approvals.