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 Cipro (ciprofloxacin), Corlopam (fenoldopam), Glucovance (glyburide and metformin), Arava (leflunomide), Viracept (nelfinavir), Concerta (methylphenidate), Zemplar (paricalcitol), Zomig (zolmitriptan), and Ortho Tri-Cyclen (norgestimate and ethinyl estradiol). The summaries are being made available consistent with 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.