Alembic Pharma bags USFDA tentative approval for Olopatadine Hydrochloride Ophthalmic Solution to treat itchy eyes
Vadodara: Alembic Pharmaceuticals Limited has 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. 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.
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) has an estimated market size of US$ 22 million for twelve months ending September 2024 according to IQVIA. Alembic has a cumulative total of 219 ANDA approvals (192 final approvals and 27 tentative approvals) from USFDA.
Medical Dialogues team had earlier reported that the Company had received final approval from the USFDA for its ANDA Alcaftadine Ophthalmic Solution, 0.25% (OTC).
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Alembic Pharmaceuticals is engaged in the development, manufacturing, and marketing of a wide range of pharmaceutical products. Founded in 1907 and headquartered in Vadodara, Gujarat, Alembic specializes in generic drugs, active pharmaceutical ingredients (APIs), and over-the-counter (OTC) products. The company has a global presence, with operations in over 75 countries, including the U.S., Europe, and emerging markets. Alembic is known for its medicines across therapeutic segments such as cardiovascular, anti-infective, pain management, and oncology.
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