Lupin Secures U.S. FDA Approval For Prednisolone Acetate Ophthalmic Suspension

Lupin, a major player in the global pharmaceutical industry, has received authorisation from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Prednisolone Acetate Ophthalmic Suspension USP, 1 per cent.

The company in a press statement on Monday informed that the product is a generic version of AbbVie Inc.'s Pred Forte Ophthalmic Suspension, 1 per cent. Lupin has also been granted Competitive Generic Therapy (CGT) designation for this product, making it eligible for 180 days of CGT exclusivity as the first approved applicant, the statement added.

The ophthalmic suspension will be manufactured at Lupin’s Pithampur facility in India. Prednisolone Acetate Ophthalmic Suspension USP, 1 per cent is prescribed for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.

The reference-listed drug (RLD), Pred Forte, had estimated annual sales of USD 198 million in the U.S. as of June 2024, according to IQVIA.