Alembic Pharma gets USFDA approval for Olopatadine Hydrochloride Ophthalmic Solution

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

New Delhi: Alembic Pharmaceuticals Limited today announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%.

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

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Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% have an estimated market size of US$ 62 million for twelve months ending December 2018 according to IQVIA. Alembic now has a total of 93 ANDA approvals (81 final approvals and 12 tentative approvals) from USFDA.

Alembic Pharmaceuticals Limited, vertically integrated research and development the pharmaceutical company has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

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