The US FDA approves Barr Laboratories' application to manufacture and market Isotretinoin capsules USP, 30 mg. The company will launch the product immediately under the trade name Claravis. The company will now market the full line of Isotretinoin product strengths, including Claravis 10 mg, 20 mg, 30 mg and 40 mg capsules.

Claravis capsules, 30 mg will compete with Ranbaxy's Sotret (Isotretinoin) capsules USP, 30 mg that had total annual sales of approximately $15 million for the most recent twelve months ending March 2006, based on IMS data.

Barr filed a Supplemental Abbreviated New Drug Application (sANDA) for the 30 mg strength of Isotretinoin capsules USP with the FDA in June 2004 seeking approval to manufacture market this additional strength.

Claravis is indicated for the treatment of severe recalcitrant nodular acne. Because of the 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.