FDA responds to Shire's Citizen Petition for Adderall XR

By Lisa Kerner

Erie, Pa., April 20 - Shire plc said it has been informed by the Food and Drug Administration that the agency hasn't resolved the issues raised in Shire's pending Adderall XR Citizen Petition, due to complex issues raised requiring extensive review and analysis by the FDA's officials.

While no decision can be reached at this time, the FDA's interim response is in accordance with regulations concerning Citizen Petitions, according to a news release.

Shire filed a Citizen Petition with the FDA to require more rigorous bioequivalence testing or additional clinical testing for generic or follow-on drug products that reference Adderall XR prior to the products' approval.

Shire is a specialty pharmaceutical company with U.S. offices in Philadelphia.

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