Daily Archives: July 28, 2016

FDA’s Latest Rx-to-OTC Switch, a Topical Retinoid for Acne Treatment

First approved in 1996, FDA recently approved a supplemental NDA (20380/S-010) for Differin® Gel (adapalene), 0.1% to be marketed as a nonprescription product in 2, 15, and 45 gram containers.  In the approval letter, FDA noted that “usage and exposure were key review issues in our evaluation of the potential risks of nonprescription marketing. Research…

Final Rule On Generic CBEs, EAR or a Variation Due April 2017

On August 29, 2011, Public Citizen filed a Citizen Petition calling for FDA to authorize ANDA holders to change approved generic labeling using Changes Being Effected (CBE) supplements (among other changes).  In response, on November 13, 2013, FDA issued notice of a proposed rule entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”…