The FDA has requested more information on MedImmune's CAIV-T, a form of the company's beleaguered FluMist that is refrigerated rather than frozen. In May the company requested FDA for clearance to market the drug to children and infants as young as six months after a late-stage trial demonstrated CAIV-T lowered the risk of flu by 55 percent in children compared to standard injectable vaccines. Now regulators say the company must provide more information on the drug. The company expects to file an sBLA within the next few weeks and hopes to market the drug for the 2007-2008 flu season.
- take a look at this press release [1] from MedImmune
Links:
[1] http://biz.yahoo.com/prnews/060718/nytu082.html?.v=57