365Telugu.com online news,Mumbai, 6th December 2024: Alembic Pharmaceuticals Limited (Alembic) has announced that it has been granted Tentative Approval by the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC).
This approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Pataday Once Daily Relief Ophthalmic Solution, 0.7%, from Alcon Laboratories, Inc. (Alcon), NDA – 206276.
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is indicated for the temporary relief of itchy eyes caused by allergens such as pollen, ragweed, grass, and animal hair and dander.
Please refer to the product label for full indications. According to IQVIA, the estimated market size for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is approximately US$ 22 million for the twelve months ending September 2024.
With this latest approval, Alembic Pharmaceuticals now has a cumulative total of 219 ANDA approvals from the USFDA, consisting of 192 final approvals and 27 tentative approvals.