Alembic Pharmaceuticals has secured US Food & Drug Administration’s (USFDA) final approval 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.
The company was granted a Competitive Generic Therapy (CGT) designation for this application. With this approval, the company is eligible for 180 days of CGT exclusivity upon commercialization. It has a cumulative total of 231 ANDA approvals (211 final approvals and 20 tentative approvals) from USFDA.
Alembic Pharmaceuticals (Alembic Pharma) is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.
