Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Alcaftadine Ophthalmic Solution, 0.25% (OTC).
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lastacaft Solution, 0.25%, of AbbVie Inc. (AbbVie). Alcaftadine Ophthalmic Solution, 0.25% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander. Refer label for a detailed indication.
Alembic has a cumulative total of 216 ANDA approvals (189 final approvals and 27 tentative approvals) from USFDA.