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Connetics Velac "not approvable" for acne

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Connetics' acne treatment Velac (clindamycin/tretinoin) is "not approvable" at FDA due to dermal carcinogenicity concerns, the company says June 13. FDA issued a "not approvable" letter on June 10, roughly two weeks ahead of a June 25 action date. Connetics believes the issue can be resolved without a new preclinical study...
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