Alembic Pharma gets USFDA nod for Azelastine Hydrochloride Ophthalmic Solution

Alembic Pharma has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Azelastine Hydrochloride Ophthalmic Solution, 0.05 per cent, Alembic Pharmaceuticals said in a BSE filing.

New Delhi: Drug firm Alembic Pharmaceuticals Friday said it has received approval from the US health regulator for Azelastine Hydrochloride Ophthalmic Solution used for treatment of allergic conjunctivitis. The approved product is therapeutically equivalent to the reference listed drug Optivar Ophthalmic Solution of Mylan Specialty L P.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Azelastine Hydrochloride Ophthalmic Solution, 0.05 per cent, Alembic Pharmaceuticals said in a BSE filing.

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Quoting IQVIA data, Alembic Pharmaceuticals said Azelastine Hydrochloride Ophthalmic Solution, 0.05 per cent, has an estimated market size of USD 8.5 million for twelve months ending December 2018.

The company currently has a total of 89 ANDA approvals (76 final approvals and 13 tentative approvals) from the USFDA, it added.

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