FDA Approves Flu Vaccine Facility For Coming Pandemic
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Subject: FDA Approves Flu Vaccine Facility For Coming Pandemic Wed Jun 18, 2014 9:23 am
FDA Approves Flu Vaccine Facility For Coming Pandemic
FDA approval of the Novartis Holly Springs facility clears the way for it to produce cell-based seasonal flu vaccine.
The US Food and Drug Administration (FDA) has approved the first US facility that can make cell-culture influenza vaccines, a Novartis plant in Holly Springs, N.C., that has been part of federal government efforts to prepare for a pandemic and to sidestep some limits of egg-based flu vaccine technology. Novartis said in a press release today that the approval clears the way for commercial production to begin at the site and for Flucelvax, its seasonal flu vaccine, to be made in the United States for the first time. The vaccine, approved in November 2012, was the first cell-based flu vaccine to receive FDA clearance, and the first doses—made in the company's German production facility—entered the US market during the 2013-14 flu season.
FDA Approves Flu Vaccine Facility For Coming Pandemic
Subject: FDA Approves Flu Vaccine Facility For Coming Pandemic 
Wed Jun 18, 2014 9:23 am
