Alembic Pharmaceuticals Receives USFDA Approval for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension

Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, 0.5%/0.3%. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb Incorporated. The product 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. Alembic was granted a Competitive Generic Therapy (CGT) designation for this application and is eligible for 180 days of CGT exclusivity upon commercialization. Alembic has a cumulative total of 231 ANDA approvals from USFDA.