Global pharma major Lupin Limited on Wednesday announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC).
According to the company’s statement, the approval has been granted to market a generic equivalent of Pataday Once Daily Relief, 0.7% (OTC), of Alcon Laboratories Inc. This product will be manufactured at Lupin’s Pithampur facility in India.
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7 percent is indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Olopatadine Hydrochloride Ophthalmic Solution USP (RLD Pataday) had an estimated annual sale of USD 22 million in the U.S. (IQVIA MAT April 2024).
