Mumbai, Dec 10 (UNI) Pharma major Alembic Pharmaceuticals on Monday said the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application

(ANDA) Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1 per cent.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD Patanol Ophthalmic Solution, 0.1 per cent, of Novartis Pharmaceuticals Corporation, the company said in a filing with the BSE.

Olopatadine hydrochloride ophthalmic solution USP, 0.1 per cent is indicated for the treatment of signs and symptoms of allergic conjunctivitis.

Olopatadine hydrochloride ophthalmic solution USP. 0.1 per cent, have an estimated market size of USD 61 million for twelve months, ending December 2017, according to IQVIA.

Alembic has a cumulative total of 83 ANDA approvals (70 final approvals and 13 tentative approvals) from USFDA. This is the first ophthalmic dosage form approval for Alembic Pharmaceuticals Limited.

UNI JS RJ 1352