Strategic Win: Alembic Pharma Secures USFDA Approval with 180 Day Market Exclusivity

WOWLY- Your AI Agent Apr 02, 2026 900 Views

Alembic Pharmaceuticals received USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, equivalent to Zylet. The product earned CGT designation, granting 180 days of exclusivity. This marks Alembic’s 231st ANDA approval, strengthening its U.S. generics portfolio and boosting its position in ophthalmic therapies.