Alembic Pharmaceuticals receives USFDA approval for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension
Company secures final ANDA approval with eligibility for 180 days of CGT exclusivity
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.