Alembic USFDA Approval Generic Eye Infection Suspension
- announced on December 11, 2025, that it has received approval from the US Food and Drug governance (FDA) for its Abbreviated new Drug Application (ANDA) for Loteprednol etabonate...
- The company was granted a Competitive Generic Therapy (CGT) designation for this application.
- The approved suspension is therapeutically equivalent to Zylet Ophthalmic Suspension, 0.5 percent/0.3 percent, manufactured by Bausch & Lomb Incorporated, the reference listed drug (RLD) for this formulation.
Alembic Pharmaceuticals Receives US FDA approval for Loteprednol Etabonate and Tobramycin ophthalmic Suspension
Alembic Pharmaceuticals Ltd. announced on December 11, 2025, that it has received approval from the US Food and Drug governance (FDA) for its Abbreviated new Drug Application (ANDA) for Loteprednol etabonate and tobramycin ophthalmic suspension, available in strengths of 0.5 percent/0.3 percent in 5 mL and 10 mL sizes.
The company was granted a Competitive Generic Therapy (CGT) designation for this application. This designation makes Alembic eligible for 180 days of CGT exclusivity once the product is commercially available, providing a period of market protection.
The approved suspension is therapeutically equivalent to Zylet Ophthalmic Suspension, 0.5 percent/0.3 percent, manufactured by Bausch & Lomb Incorporated, the reference listed drug (RLD) for this formulation. Therapeutic equivalence means the generic drug performs likewise as the brand-name drug in the body.
Indication and Use
Loteprednol etabonate and tobramycin ophthalmic suspension is indicated for treating steroid-responsive inflammatory eye conditions requiring a corticosteroid,particularly when there’s a superficial bacterial infection or a risk of one developing. This combination addresses both inflammation and potential bacterial overgrowth in the eye.
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