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

 

ADVERSE REACTIONS

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.

 

Hide
(web2)