Lupin receives tentative approval for Olopatadine Hydrochloride Ophthalmic Solution
The drug is a generic equivalent of Pataday Once Daily Relief, 0.7 per cent (OTC)
Lupin announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7 per cent (OTC), to market a generic equivalent of Pataday Once Daily Relief, 0.7 per cent (OTC), of Alcon Laboratories. This product will be manufactured at Lupin’s Pithampur facility in India.
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7 per cent 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 US (IQVIA MAT April 2024).
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