NEVER SAY NEVER!!!
Wednesday July 28 2:40 AM ET
FDA Approves Flu Inhalant Drug
By PAUL RECER AP Science Writer
WASHINGTON (AP) - Ignoring the recommendation of its own advisory panel, the Food and Drug Administration approved an inhalant drug for the treatment of simple influenza.
Studies show the drug, to be marketed under the name Relenza, can reduce the duration of flu symptoms by up to 36 hours, but critics said the benefit does not justify approval.
An FDA advisory panel voted 13-4 in February against recommending approval of Relenza, saying the drug helped flu sufferers only slightly. The panel requested more studies, particularly among people in nursing homes and the elderly.
Dr. Heidi M. Jolson, director of the FDA's antiviral drug product division, said approving a drug against the recommendation of an advisory committee ''doesn't happen commonly'' but Relenza adds a new weapon to the very limited flu-fighting arsenal. She said the need for some therapy against flu was a strong element in the decision.
''Influenza is an important public health problem, and this will provide another option for treatment,'' she said.
Jolson said that since the advisory committee vote last February, the drug manufacturer, GlaxoWellcome Inc., has provided information to answer many of the questions raised during the panel's hearing.
''We felt we had sufficiently addressed the concerns that the advisory committee had brought up,'' Jolson said.
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