adapalene and benzoyl peroxide — Glenmark Pharmaceuticals Inc., USA drug label update
Glenmark Pharmaceuticals Inc., USA has updated the drug label for its adapalene and benzoyl peroxide gel, which is indicated for the topical treatment of acne vulgaris in patients aged 9 years and older.
This update affects Glenmark Pharmaceuticals Inc., USA, as well as regulatory affairs and labeling professionals responsible for managing topical retinoid and benzoyl peroxide combination products.
The update confirms the specific age range and pharmacological classification (retinoid and benzoyl peroxide combination) for this topical treatment. Regulatory teams may find this relevant for maintaining labeling compliance regarding pediatric use and indication statements for generic or equivalent formulations.
Regulatory and labeling teams should ensure that all topical acne product documentation reflects the specific age indications and combination drug classification. Quality departments should verify that labeling materials match the updated prescribing information for the 9 years and older demographic.
adapalene and benzoyl peroxide (Glenmark Pharmaceuticals Inc., USA). 1 INDICATIONS AND USAGE Adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adapalene and benzoyl peroxide gel is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ( 1 )
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