Richwood Adderall will be available again under IND exemption for hyperactivity disorder.
Executive Summary
RICHWOOD ADDERALL AVAILABLE UNDER IND EXEMPTION for patients with attention deficit hyperactivity disorder until the company can get approval of an NDA supplement for the combination amphetamine product. Under an IND approved March 3, distribution is limited to "only those patients who have been on Adderall/Obetrol during the past year and whose physicians certify that they do not respond satisfactorily to currently marketed single ingredient amphetamines," FDA said in a March 6 document explaining the regulatory status of the product. Richwood has resumed Adderall production and expects patients to begin receiving the drug under the IND by March 17.
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