Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application 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, 0.7%, of Alcon Laboratories, Inc. (Alcon). Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7%, is indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander. Refer label for a detailed indication and usage.

According to IQVIA, Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7%, had an estimated market size of US$20 million in the United States for twelve months ending September 2026.

This ANDA was developed in collaboration with Orbicular Pharmaceutical Technologies.

Alembic has a cumulative total of 248 ANDA approvals (229 final approvals and 19 tentative approvals) from the USFDA.