Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability

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The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for ADDERALL XR (mixed salts of a single-entity amphetamine product), AVANDIA (rosiglitazone), AVAPRO (irbesartan), RAPAMUNE (sirolimus), and ZOFRAN (ondansetron). These summaries are being made available consistent with section 9 of the Best Pharmaceuticals for Children Act (BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.