Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension in strengths of 0.5 percent and 0.3 percent, available in 5 mL and 10 mL presentations. This product is the generic version of the reference drug Zylet Ophthalmic Suspension, used to treat steroid-responsive inflammatory eye conditions where a corticosteroid is needed and where a superficial bacterial infection is present or likely to occur.

The product has been granted Competitive Generic Therapy (CGT) designation, making Alembic eligible for 180 days of market exclusivity in the USA once the product is launched. This exclusivity period provides a significant commercial advantage by limiting competition during initial marketing.

This approval strengthens Alembic’s expanding portfolio in the US generics market. With this approval, the company now holds 231 ANDA approvals, of which 211 are final approvals and 20 are tentative. The milestone highlights Alembic’s continued progress in developing complex generics and expanding its footprint in regulated global markets.

Loteprednol Etabonate and Tobramycin Ophthalmic Suspension combines an anti-inflammatory corticosteroid with an antibiotic, offering a comprehensive treatment option for managing ocular inflammation alongside the risk of bacterial infection. The FDA approval reinforces Alembic’s capabilities in ophthalmic formulations and enhances treatment availability for clinicians and patients.