Teva Announces FDA Approval of Bid to Sell Generic of Shire’s ADHD Drug Adderall XR

Teva Pharmaceutical Industries Ltd. Feb. 14 said that the Food and Drug Administration approved the company’s abbreviated new drug application (ANDA) to make a generic version of Shire’s Adderall XR capsules in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strengths.

Adderall XR (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules) is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.

According to IMS sales data, Adderall XR had annual sales, including brand and generic sales, of approximately $2 billion in the United States.

Israel-based Teva currently sells a ...