Revised labeling issued June 8 changes indication of isotretinoin to "severe recalcitrant nodular acne" from "severe recalcitrant cystic acne." The revisions reflect current clinical practice guidelines developed by the American Academy of Dermatology, Roche explains. Contraindications for pregnancy also were changed to reflect 1991 recommendations of FDA's Dermatologic Drugs and Fertility & Maternal Health Advisory Committees ("The Pink Sheet" May 27, 1991, p. 7)
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