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Alembic Pharma receives USFDA's tentative approval for Olopatadine Hydrochloride Ophthalmic Solution

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Alembic Pharmaceuticals announced that it has received Tentative Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pataday Once Daily Relief Ophthalmic Solution, 0.7%, of Alcon Laboratories, Inc. (Alcon) NDA - 206276.

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander.

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First Published: Dec 04 2024 | 4:41 PM IST

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