Lupin has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Suspension, 0.2%, to market a generic equivalent to the reference listed drug (RLD) Alrex Ophthalmic Suspension, 0.2%, of Bausch & Lomb Inc.
The product will be manufactured at Lupin’s Pithampur facility in India. Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis. Loteprednol Etabonate Ophthalmic Suspension, 0.2% (RLD Alrex), had estimated annual sales of $29.1 million in the U.S. (IQVIA MAT October 2023).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
Company Name | CMP |
---|---|
Sun Pharma Inds. | 1814.50 |
Dr. Reddys Lab | 1340.80 |
Cipla | 1476.45 |
Lupin | 2160.20 |
Zydus Lifesciences | 972.95 |
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