NEW YORK - October 26, 2009 - An experimental drug, Peramivir, is currently being developed by BioCryst Pharmaceuticals Inc. and is undergoing testing required for regular FDA approval.
The Food and Drug Administration issued a so-called emergency use authorization late Friday that allows doctors to use Peramivir, which is delivered intravenously, in certain hospitalized adult and pediatric patients with confirmed or suspected H1N1 influenza.
A handful of doctors have already treated patients with severe cases of H1N1 using Peramivir obtained through the agency's expanded access rules that allow individual patients to obtain experimental drugs if certain conditions are met. The emergency-use authorization allows use of the drug without prior FDA approval.
The Food and Drug Administration issued a so-called emergency use authorization late Friday that allows doctors to use Peramivir, which is delivered intravenously, in certain hospitalized adult and pediatric patients with confirmed or suspected H1N1 influenza.
A handful of doctors have already treated patients with severe cases of H1N1 using Peramivir obtained through the agency's expanded access rules that allow individual patients to obtain experimental drugs if certain conditions are met. The emergency-use authorization allows use of the drug without prior FDA approval.