Barr Laboratories has announced that the FDA has approved its application to manufacture and market a generic version of Accutane tablet (canadian isotretinoin, Roche) capsules, in strengths of 10, 20, and 40 mg. The company plans to market Clar-avisTM as a generic brand and to launch it in May 2003.
ClaravisTM is indicated for the treatment of severe recalcitrant nodular acne. Because of the significant adverse effects associated with its use, this drug should be reserved for those patients who have not responded to conventional therapy, including systemic antibiotics. The drug is indicated only for women who are not pregnant and will not become pregnant.