Mumbai: Global pharma major Lupin Limited today 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).
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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 U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.8% of its revenue in research and development in FY24.
Lupin has 15 manufacturing sites, 7 research centers.
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