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06 Aug 2024
Admin
News Article

Lupin Receives US FDA Approval for Prednisolone Acetate Ophthalmic Suspension USP

Overview

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for prednisolone acetate ophthalmic suspension USP, 1% to market a generic equivalent of Pred Forte ophthalmic suspension, 1%, of AbbVie Inc. Lupin was granted a competitive generic therapy designation (CGT) for this product, and being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity.

Manufacturing area- The product will be manufactured at Lupin’s Pithampur facility in India.

Indication- Prednisolone acetate ophthalmic suspension USP, 1% is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

Estimated annual sales- Prednisolone acetate ophthalmic suspension USP, 1% (RLD Pred Forte) had estimated annual sales of USD 198 million in the US (IQVIA MAT June 2024).

About Lupin

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.
The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

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