Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb

Alembic Pharmaceuticals Limited (Alembic) 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% (5 mL and 10 mL). 

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb Incorporated. 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. Refer label for a detailed indication. 

Alembic was granted a Competitive Generic Therapy (CGT) designation for this application. With this approval, Alembic is eligible for 180 days of CGT exclusivity upon commercialization. 

Alembic has a cumulative total of 231 ANDA approvals (211 final approvals and 20 tentative approvals) from USFDA.