NEW DELHI: Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market Alcaftadine ophthalmic solution, in the American market.
The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Alcaftadine Ophthalmic Solution, Alembic Pharmaceuticals said in a regulatory filing.
The approved ANDA is therapeutically equivalent to Allergan, Inc’s Lastacaft Ophthalmic Solution, 0.25 per cent.The product is indicated for the prevention of itching associated with allergic conjunctivitis in eyes.
According to IQVIA data, Alcaftadine has an estimated market size of USD 7 million for twelve months ending December 2019. Alembic said it has now a cumulative total of 120 ANDA approvals from the USFDA.