Alembic wins USFDA approval for ophthalmic suspension

Alembic Pharmaceuticals Limited 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%/0.3% (5 mL and 10 mL). This approval makes the company eligible for 180 days of Competitive Generic Therapy (CGT) exclusivity upon commercialization.

The approved ANDA is therapeutically equivalent to the reference listed drug, Zylet Ophthalmic Suspension, and is indicated for steroid-responsive inflammatory ocular conditions with existing or potential bacterial ocular infection. This latest approval contributes to Alembic's cumulative total of 231 ANDA approvals, comprising 211 final and 20 tentative approvals from the USFDA.