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

Resumo

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 Ciloxan (ciprofloxacin ophthalmic), Brevibloc (esmolol), Flovent (fluticasone), Fludara (fludarabine), Fosamax (alendronate), Lotensin (benazepril), Malarone (atovaquone and proguanil), Xenical (orlistat), and Ocuflox (ofloxacin ophthalmic). The 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.