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Alembic Pharma Gains USFDA Approval for OTC Alcaftadine Ophthalmic Solution

• 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. • This approval brings Alembic's total ANDA approvals from the USFDA to 216, comprising 189 final and 27 tentative approvals.

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.
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Reference News

[1]
Alembic Pharmaceuticals announces USFDA Final Approval for Alcaftadine Ophthalmic ...
passionateinmarketing.com · Oct 5, 2024

Alembic Pharmaceuticals received USFDA approval for its Alcaftadine Ophthalmic Solution, 0.25% (OTC), equivalent to AbbV...

[2]
Alembic receives USFDA final approval for Alcaftadine Ophthalmic Solution, 0.25% (OTC)
indianpharmapost.com · Oct 4, 2024

Alembic receives USFDA final approval for Alcaftadine Ophthalmic Solution, 0.25% (OTC), used to relieve itchy eyes due t...

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