April 20, 2020: “Alembic Pharmaceuticals Limited (Alembic) announced it has received tentative approval from the US Food & Drug Administration (USFDA) 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. (Allergan).
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 USFDA.”
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