No FDA decision yet on Adderall Citizen Petition

UK-based drugmaker Shire Pharmaceuticals says that the US Food and Drug Administration has notified it that the agency has not yet settled issues raised by the firm's pending Adderall XR (mixed amphetamine salts) Citizen Petition.

This formulation of the drug, which is intended for the treatment of attention-deficit hyperactivity disorder, was approved in the USA in late 2001 (Marketletters passim). Since then, however, the product has faced a series of challenges to its patent from several firms wishing to sell generic versions of the drug

In October 2005, Shire filed a Citizen Petition with the FDA requesting that more rigorous bioequivalence testing or additional clinical examination of generic or follow-on products that reference Adderal XR be undertaken before such products are approved. The firm adds that such measures will both allow it to defend its product and ensure that generic versions are safe and effective.