From Earlier: Shire Announces that the US Food and Drug Administration has Responded to its Citizen Petition for Adderall XR and has Approved One Abbreviated New Drug Application for Generic Adderall XR

Shire plc

announced that on June 22, 2012, the US Food and Drug Administration (FDA) responded to Shire's Adderall XR citizen petition. The FDA's response requires that all abbreviated new drug applications (ANDAs) have to establish bioequivalence using partial area under the curve measurements at 5 hours and beyond 5 hours, for both d- and l- amphetamine. The FDA response is consistent with its recent decisions on other long acting ADHD products. The FDA also informed Shire on June 22, 2012 that it has approved the ANDA for generic Adderall XR filed by Actavis. The FDA has not approved any other Adderall XR ANDAs.