26-Jun-2026 19:12:52

APLLTDGeneral news

ALEMBIC PHARMACEUTICALS : RECEIVES USFDA FINAL APPROVAL FOR DAPSONE GEL, 5%

• Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapsone Gel, 5%. • The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Aczone Gel, 5%, of Almirall, LLC. • Dapsone Gel is indicated for the topical treatment of acne vulgaris. • Alembic has a cumulative total of 244 ANDA approvals (224 final approvals and 20 tentative approvals) from USFDA.

Alembic Pharmaceuticals Limited

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