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 has shown that increased package sizing of products leads to increased usage among consumers. Conversely, limiting package sizes has been shown to reduce overconsumption by limiting the immediate availability of drugs to the consumer.”  Click here for the full story or here to learn more about OTC drug development.

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