FDA Responds to Shire’s Citizen Petition Regarding Generic Versions of Adderall XR

Shire Plc June 23 announced that the Food and Drug Administration has responded to its citizen petition regarding generic versions of its Adderall XR (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate) extended-release capsules.

Adderall is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.

In the citizen petition submitted in 2005, Shire requested that FDA apply a more stringent bioequivalence requirement including additional partial area-under-the-concentration-time curve (partial AUC) measurements for approval of any abbreviated new drug application (ANDA) for generic versions of Adderall XR. Shire also requested that FDA require a clinical efficacy study in ...