Attention Deficit Disorder

Generic Dexedrine Spansule Capsules Approved

Published in Medical Letter on the CDC and FDA, February 17th, 2002

The U.S. Food and Drug Administration (FDA) has approved Barr Laboratories' application to manufacture and market a generic version of GlaxoSmithKline's Dexedrine Spansule Capsules sustained release 5 mg, 10 mg and 15 mg. Barr expects to be the first to market generic dexedrine spansule.

"The approval of generic dexedrine spansule represents the company's ninth approval this fiscal year and the second product in our generic portfolio for the treatment of attention deficit disorder," said Bruce L. Downey, Barr's chairman and CEO. "With the anticipated approval of our generic Adderall application, which is currently pending at the FDA, Barr will be a leading provider of...

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Source: Medical Letter on the CDC and FDA (2002-02-17)

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