Alembic gets USFDA nod for generic eye infection treatment suspension

Alembic Pharmaceuticals Ltd on Thursday said it has received final approval from the US health regulator for its generic version of Loteprednol Etabonate and Tobramycin ophthalmic suspension used for treatment of eye infection.

The approval granted by the US Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) Loteprednol Etabonate and Tobramycin Ophthalmic Suspension of strength 0.5 per cent/0.3 per cent (5 mL and 10 mL), Alembic Pharmaceuticals Ltd said in a regulatory filing.

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 commercialisation, it added.

 

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5 per cent/0.3 per cent, of Bausch & Lomb Incorporated, the company said.

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 company said.