Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD Patanol Ophthalmic Solution, 0.1%, of Novartis Pharmaceuticals Corporation. Olopatadine hydrochloride ophthalmic solution USP, 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.
Olopatadine hydrochloride ophthalmic solution USP, 0.1 %, have an estimated market size of $ 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 first ophthalmic dosage form approval for Alembic pharmaceuticals.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
