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Description

Kirby, R

10.1096/fj.11-187401 FASEB J

doi: 10.1016/j.jep.2016.05.033

Isotretinoin (Accutane)

Unapproved New Drug: Any substance that has not completed the formal FDA approval process and fails to qualify for a strict 503A or 503B exemption is classified as an unapproved new drug, the distribution of which is prohibited in interstate commerce