Alembic Pharmaceuticals receives USFDA tentative approval for Alcaftadine Ophthalmic Solution

Alembic Pharmaceuticals announced that 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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