2004S-0212 - Pandemic Influenza Preparedness Plan
FDA Comment Number : EC20
Submitter : Dr. Michael Ossi Date & Time: 11/09/2004 01:11:54
Organization : GlaxoSmithKline
Drug Industry
Category :
Issue Areas/Comments
On behalf of GSK, we would like to acknowledge the work that has gone into preparing this plan. We do not have any specific comments as related to the strategic content outlined in the document. With regard to use of antivirals, Relenza (zanamivir for inhalation) is accurately represented. Availability in the United States as noted has been limited due to low demand; however, GSK is willing to work with the agency on stockpiling strategies and is actively looking for ways to increase availability for this purpose. As a reminder, zanamivir is an active antiviral agent against the influenza virus and has demonstrated potent activity in vitro and in animal models against the H5N1 as well as other avian subtypes. We appreciate the opportunity to comment, and we want to continue to be an active participant in pandemic preparedness planning.