Alembic Pharma Gains USFDA Approval for OTC Alcaftadine Ophthalmic Solution

Key Insights

• Alembic Pharmaceuticals secures USFDA final approval for its Abbreviated New Drug Application (ANDA) for Alcaftadine Ophthalmic Solution, 0.25% (OTC).
• The approved ANDA is therapeutically equivalent to AbbVie's Lastacaft Solution, 0.25%, offering a more accessible option for patients.
• Alcaftadine Ophthalmic Solution is indicated for temporary relief of itchy eyes caused by allergens like pollen, ragweed, grass, animal hair, and dander.

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Alcaftadine Ophthalmic Solution, 0.25% (OTC). This approval marks a significant step in providing accessible relief for individuals suffering from allergic conjunctivitis.

The approved ANDA is therapeutically equivalent to AbbVie's Lastacaft Solution, 0.25%. Alcaftadine Ophthalmic Solution is indicated for the temporary relief of itchy eyes due to common allergens such as pollen, ragweed, grass, animal hair, and dander. This over-the-counter availability will allow easier access for patients experiencing these symptoms.

With this approval, Alembic Pharmaceuticals now holds a cumulative total of 216 ANDA approvals from the USFDA, consisting of 189 final approvals and 27 tentative approvals. This milestone underscores Alembic's commitment to expanding its portfolio of accessible and affordable medications.