Lupin Launches Loteprednol Etabonate Ophthalmic Suspension, 0.5%, in the U.S. Market

Lupin Limited has officially launched loteprednol etabonate ophthalmic suspension, 0.5%, in the United States. This launch expands the company’s ophthalmic portfolio and brings a new generic alternative to an established corticosteroid therapy.

Bioequivalent to Lotemax Ophthalmic Suspension

The newly launched product is bioequivalent to Bausch & Lomb’s Lotemax Ophthalmic Suspension, 0.5%, a widely prescribed corticosteroid formulation. Loteprednol etabonate ophthalmic suspension, 0.5% is indicated for the treatment of steroid-responsive inflammatory conditions affecting the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, in cases where the benefits of steroid use outweigh potential risks.

Additionally, it is approved for the treatment of postoperative inflammation following ocular surgery, providing clinicians with a reliable anti-inflammatory option for managing surgical recovery.

FDA Approval for Loteprednol Etabonate Ophthalmic Gel, 0.38%

In a related development, Lupin also announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company’s Abbreviated New Drug Application (ANDA) for loteprednol etabonate ophthalmic gel, 0.38%.

This gel formulation, bioequivalent to Bausch & Lomb’s Lotemax SM Ophthalmic Gel, is specifically indicated for the treatment of postoperative inflammation and pain following ocular surgery.