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Alembic Pharmaceuticals Receives US FDA Approval for Dapsone Gel 5 Percent

Alembic Pharmaceuticals Receives US FDA Approval for Dapsone Gel 5 Percent

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Dapsone Gel, 5 percent.

Dapsone Gel is indicated for the topical treatment of acne vulgaris.

The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Aczone Gel, 5 percent, of Almirall, LLC.

Alembic has a cumulative total of 244 ANDA approvals (224 final approvals and 20 tentative approvals) from FDA.
Read more on:
Acne vulgaris treatment Aczone Gel Alembic Pharmaceuticals ANDA approval Dapsone Gel Topical acne treatment US FDA approval
More news about: regulation | Published by News Bureau | June - 29 - 2026

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