ZIANA — Bausch Health US, LLC drug label update
Bausch Health US, LLC has updated the drug label for ZIANA (clindamycin phosphate and tretinoin) Gel, confirming its indication for the topical treatment of acne vulgaris in patients 12 years of age and older.
This update affects Bausch Health US, LLC, as well as regulatory and compliance professionals involved in the labeling and distribution of topical combination acne treatments.
The update reinforces the specific age threshold for the safe and effective use of this lincosamide antibiotic and retinoid combination. While the source does not detail specific changes from previous versions, the label update suggests a formalization of clinical indications that regulatory teams must reflect in all downstream compliance documentation and safety reporting structures.
Regulatory and labeling teams should verify that all current product inserts and marketing materials for ZIANA Gel align with the age-specific indication (12 years or older). Operations should ensure that any pending batch releases utilize the updated labeling documentation as required by the drug label update.
ZIANA (Bausch Health US, LLC). 1 INDICATIONS AND USAGE ZIANA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. ZIANA ® Gel is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years or older. ( 1 )
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