Alembic Pharma receives USFDA tentative approval for Alcaftadine ophthalmic solution

Alembic Pharmaceuticals Limited has received tentative approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Alcaftadine ophthalmic solution, 0.25 percent. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Lastacaft ophthalmic solution, 0.25 percent, 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 percent had an estimated market size of USD 7 million for 12 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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