Team siliconindia

• Alembic receives USFDA final approval for its generic Loteprednol Etabonate and Tobramycin eye suspension.
• The product earns Competitive Generic Therapy (CGT) status, giving the company 180-day exclusivity.
• Alembic now holds 231 ANDA approvals, strengthening its U.S. generics portfolio.

Alembic Pharmaceuticals Ltd. has received final approval from the U.S. Food & Drug Administration (USFDA) for its generic Loteprednol Etabonate and Tobramycin Ophthalmic Suspension (0.5%/0.3%) in 5 mL and 10 mL presentations. The approval confirms the drug’s therapeutic equivalence to Zylet, the reference product developed by Bausch & Lomb.

The combination eye medication is used to treat steroid-responsive inflammatory eye conditions where there is an existing bacterial infection or a risk of one developing. It provides both anti-inflammatory and antibacterial action, offering doctors a reliable alternative for managing complex ocular conditions.

The approved product has earned Competitive Generic Therapy (CGT) designation, making Alembic eligible for 180 days of marketing exclusivity after the product is launched in the U.S. market. This exclusivity is expected to give the company a strong advantage in a competitive therapeutic category.

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With this approval, Alembic has reached a significant milestone 231 total ANDA approvals, including 211 final and 20 tentative nods from the USFDA. The company continues to expand its global footprint with a steady pipeline of generic medicines.