USFDA approves generic loteprednol etabonate ophthalmic suspension made by Lupine
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| USFDA approves generic loteprednol etabonate ophthalmic suspension made by Lupine |
According to a regulatory filing by Lupine, the US Food and Drug Administration (USFDA) has approved an abbreviated new drug application for loteprednol etabonate ophthalmic solution, 0.2%.
It is a generic version of Bausch & Lomb Inc.'s Alrex ophthalmic suspension, 0.2 percent, which is the reference listed drug (RLD).
The US health authorities has approved generic loteprednol etabonate ophthalmic solution for sale, Lupine Ltd, a major pharmaceutical company, announced on Wednesday. The medication is intended to provide short-term treatment from seasonal allergic conjunctivitis.
According to a regulatory filing by Lupine, the US Food and Drug Administration (USFDA) has approved an abbreviated new drug application for loteprednol etabonate ophthalmic solution, 0.2%.
It is a generic version of Bausch & Lomb Inc.'s Alrex ophthalmic suspension, 0.2 percent, which is the reference listed drug (RLD).
The product will be produced in Lupine's Pithampur factory in India, according to the firm.
The 0.2 percent loteprednol etabonate ophthalmic fluid is recommended for the short-term alleviation of seasonal allergic conjunctivitis symptoms.
Lupine said that it had projected yearly sales of US$29.1 million in the US market, using IQVIA MAT October 2023 data.
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