Company: Today’s Business
Product:”Isotrex Isotretinoina Gel 0.05%”
Date: 9/9/03
“Accutane must not be used by females who are pregnant…must be prescribed under the System to Manage Accutane Related Teratogenicity (S.M.A.R.T.), a yellow Accutane Qualification Sticker must be on each prescription,” (meaning special training has been given to the prescribing licensed practitioner and the patient) “and no telephone or computerized prescriptions are permitted.” The approved Accutane is for oral ingestion. FDA has not approved a topical gel version of Accutane or any other isotretinoin drug.
Issuer: Center for Drug Evaluation and Research (CDER)
