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Label Changes for:

Differin (Adapalene) Lotion

April 2013

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013



Clinical Studies Experience
  • In an open label postmarketing pharmacokinetic trial of 13 adolescent subjects, the adverse event of pruritus was reported in 8 out of 13 subjects.