Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP

Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (U.S. 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.

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

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.

Prednisolone Acetate Ophthalmic Suspension USP, 1% (RLD Pred Forte) had estimated annual sales of USD 198 million in the U.S. (IQVIA MAT June 2024).