Alembic Pharmaceuticals Limited has announced that it received final approval from the U.S. Food and Drug Administration (USFDA) for its over-the-counter (OTC) Alcaftadine Ophthalmic Solution, 0.25%. The product is a generic version of AbbVie Inc.’s Lastacaft Solution and is used to temporarily relieve itchy eyes caused by allergens like pollen, grass, ragweed, animal hair, and dander.
This approval marks Alembic’s cumulative total of 216 Abbreviated New Drug Application (ANDA) approvals from the USFDA, which includes 189 final approvals and 27 tentative approvals.
Alembic Pharmaceuticals, a leading pharmaceutical company since 1907, specializes in research, development, manufacturing, and marketing of generic pharmaceutical products worldwide. Its facilities have been approved by multiple regulatory bodies, including the USFDA.
