Alembic Pharma gets USFDA Final Approval for Olopatadine HCl Ophthalmic Solution

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). This product is therapeutically equivalent to Alcon Laboratories' Pataday Once Daily Relief, 0.7%. The estimated market size for this product in the US was approximately US$20 million for the twelve months ending September 2026. This ANDA was developed in collaboration with Orbicular Pharmaceutical Technologies Pvt Ltd. Alembic now has a total of 248 ANDA approvals from the USFDA, including 229 final approvals.