Zdrowie i gospodarka · 22/10/2004

Request for Public Comment on a Written Request Issued by the Food and Drug Administration on the Use of Oral Azithromycin for the Treatment or Prevention of Pneumonia or Conjunctivitis Caused by Chlamydia Trachomatis in Infants

The National Institutes of Health (NIH) is requesting public comment on the following Written Request issued by the Food and Drug Administration (FDA) for off-patent drugs as defined in the Best Pharmaceuticals for Children Act (BPCA). The Written Request was referred to the NIH by the FDA as required by the BPCA. The Written Request was developed following formulation of an NIH-generated priority list, which prioritizes certain drugs most in need of study for use by children. The priority list was produced in consultation with the FDA, other NIH Institutes and Centers, and pediatric experts, as mandated by the BPCA. The studies that are described in the Written Request are intended to characterize the safety, efficacy, and pharmacokinetics of the drug for optimum use in pediatric patients.