title: Are we underdosing acne patients with generic isotretinoin?
abstract: With Roche's withdrawl of Accutane from the U.S. market in 2009, isotretinoin has only been available in its generic form. Many clinicians fail to realize that for approval by the U.S. Food and Drug Administration, a generic medication must have a bioequivalence between 80 percent and 125 percent of that of the innovator product. This potential variability in bioavailability between branded and generic medications is important to keep in mind with isotretinoin, given the implications for achieving a sustained remission in acne patients.
authors: Division of Dermatology, Washington University School of Medicine, St. Louis, MO, USA.
authors: Misha M
authors: MM
authors: Mutizwa
authors: David M
authors: DM
authors: Sheinbein
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D016568:Drugs, Generic / Q000008:administration & dosage* / Q000592:standards; D006801:Humans; D015474:Isotretinoin / Q000008:administration & dosage*; D013810:Therapeutic Equivalency
chemical_list: D016568:Drugs, Generic; D015474:Isotretinoin