Alembic Pharmaceuticals Limited has received tentative approval from the US Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) alcaftadine ophthalmic solution, 0.25%.



The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Lastacaft ophthalmic solution, 0.25%, of Allergan, Inc.



Alcaftadine ophthalmic solution is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.



Alcaftadine ophthalmic solution, 0.25% has an estimated market size of US$ 7 million for twelve months ending December 2019, according to IQVIA.



Alembic has a cumulative total of 120 ANDA approvals (107 final approvals and 13 tentative approvals) from US FDA.