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Barr Laboratories, Inc.



Approval granted for generic Accutane



May 14th, 2003

Barr Laboratories, Inc., (BRL) announced that the U.S. Food & Drug Administration (FDA) has approved its application to manufacture and market a generic version of Roche Pharmaceutical's Accutane Capsules, 10 mg, 20 mg, and 40 mg.

The company plans to market the product as a generic under the trademark name Claravis. The company plans to launch the product in May.

"With the approval of Claravis, the company demonstrates our ability to successfully develop complex generic products," said Bruce L. Downey, Barr's chairman and CEO. "We also have established an extensive educational program, including dissemination of educational materials to physicians...


Source: Biotech Week (2003-05-14)

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