Alembic Pharmaceuticals Limited has secured 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 product is therapeutically equivalent to Pataday Once Daily Relief, a drug marketed by Alcon Laboratories, Inc.
Olopatadine hydrochloride solution is indicated for the temporary relief of itchy eyes caused by allergens like pollen, ragweed, grass, and animal dander. The product has an estimated market size of USD 22 million for the twelve months ending September 2024, according to IQVIA.
This latest approval marks Alembic’s 219th ANDA approval from the USFDA, comprising 192 final approvals and 27 tentative approvals.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals, a leading research-driven pharmaceutical company established in 1907, specializes in branded generics and global pharmaceutical products. With state-of-the-art research and manufacturing facilities, Alembic remains a significant contributor to the healthcare industry worldwide.
