Generic Drugs

Filing for generic version of Adderall XR accepted by FDA

Published in Medical Letter on the CDC and FDA, December 21st, 2003

IMPAX Laboratories, Inc., (IPXL) announced that the U.S. Food and Drug Administration (FDA) has accepted the company's filing of an abbreviated new drug application for a generic version of Adderall XR 30 mg Capsules.

Adderall XR is a once-daily, extended-release, mixed salts of a single-entity amphetamine product. Shire Pharmaceuticals Group, plc, (SHPGY) markets the product for the treatment of attention deficit and hyperactivity disorder.

According to NDCHealth, U.S. sales of Adderall XR Capsules were approximately $540 million in the 12 months ended September 30, 2003. Shire received initial FDA approval of this product in October of 2001.

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Source: Medical Letter on the CDC and FDA (2003-12-21)

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