FDA confirms reasons for Accutane withdrawal to Sun
This article was originally published in Scrip
Executive Summary
In response to a citizen petition filed by Sun Pharmaceutical, the US FDA has reviewed its records and determined that Roche's branded product, Accutane (isotretinoin), was not withdrawn from sale for reasons of safety or effectiveness, according to a Federal Register notice. Thus, the agency will continue to allow generic isotretinoin products to be marketed; the product was approved for severe acne treatment and first became available back in 1982.