Alembic Pharma Receives USFDA Approval for Olopatadine Hydrochloride Ophthalmic Solution

Alembic Pharmaceuticals Limited announced that 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 percent. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD Patanol Ophthalmic Solution, 0.1 percent, of Novartis Pharmaceuticals Corporation. Olopatadine hydrochloride ophthalmic solution USP, 0.1 percent is indicated for the treatment of the signs and symptoms of allergic conjunctiviti’s. Olopatadine hydrochloride ophthalmic solution USP. 0.1 percent, 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 first ophthalmic dosage form approval for Alembic pharmaceuticals Limited. – Medical Buyer Bureau