Alembic Pharmaceuticals gets USFDA nod for generic acne treatment gel
Alembic Pharmaceuticals has secured final USFDA approval for its generic Dapsone gel, a topical treatment for acne vulgaris. This approval, for the 5% strength, means the company can now market its version, which is therapeutically equivalent to A...
By PTI |
New Delhi: Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for the generic version of Dapsone gel indicated for the topical treatment of acne vulgaris.
The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dapsone gel, 5 per cent, Alembic Pharmaceuticals said in a statement.
The approved ANDA is therapeutically equivalent to the reference listed drug product Aczone Gel, 5 per cent of Almirall, LLC, it added.
Read More:Alembic Pharma gets USFDA nod for generic influenza treatment drug
Dapsone gel is indicated for the topical treatment of acne vulgaris, the company said.
The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dapsone gel, 5 per cent, Alembic Pharmaceuticals said in a statement.
The approved ANDA is therapeutically equivalent to the reference listed drug product Aczone Gel, 5 per cent of Almirall, LLC, it added.
Read More:Alembic Pharma gets USFDA nod for generic influenza treatment drug
Dapsone gel is indicated for the topical treatment of acne vulgaris, the company said.
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