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FDA Approves Generic Adderall XR for Attention Deficit Disorder

Amphetamine product indicated for children, adolescents, and adults (Feb. 14)

The FDA has approved an abbreviated new drug application (ANDA) for a generic version of Adderall XR capsules (Shire) 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg for the treatment of attention deficit hyperactivity disorder (ADHD). The generic version will be marketed by Teva Pharmaceuticals.

Adderall XR had annual sales, including brand and generic sales, of approximately $2 billion in the U.S., based on IMS sales data as of December 31, 2012.

Teva currently sells a generic version of Adderall XR capsules under a 2006 license and distribution agreement with Shire as part of a settlement of patent litigation between Shire and Barr Pharmaceuticals, a Teva subsidiary.

Adderall XR is a once-daily extended-release, single-entity amphetamine product. It has been designated as a Schedule II controlled substance (CII).

Sources: Teva Pharmaceuticals; February 14, 2013; and Adderall XR PI; January 2013.

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