13 May 2003 -
Barr Laboratories, Inc. today announced that it has launched its AB-rated generic equivalent version of Roche Pharmaceutical's Accutane(R) Capsules, 10 mg, 20 mg and 40 mg, under the trademark name Claravis(TM) (Isotretinoin Capsules, USP). The U.S. Food & Drug Administration (FDA) approved the Company's application to manufacture and market Claravis in April 2003.
The Company will promote Claravis to dermatologists using its sales force that currently markets Trexall(TM) (Methotrexate Tablets, USP). Barr's comprehensive education, risk assessment and management program for patients, pharmacists and physicians includes, but is not limited to, a toll free registration program for prescriber registration and education, a website for healthcare professionals and patients, patient education materials designed to inform patients about the risks associated with use of Claravis, and a pregnancy prevention program. The risk management aspects of the program include pregnancy testing and avoidance, patient awareness and consent to avoid pregnancy, and awareness of psychiatric disorders prior to and during therapy, because Claravis can cause birth defects.
Claravis is indicated for the treatment of severe recalcitrant nodular acne. Because of significant adverse effects associated with its use, Claravis should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, for female patients of childbearing potential, Claravis is indicated only for those females who are not pregnant and will not become pregnant.
Claravis will compete in the Accutane marketplace that had total annual sales of approximately $536 million for the most recent twelve months ended March 2003
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