Valneva SE Wins FDA Market Exclusivity for the Pediatric Indication of IXIARO in the United States


Friday, 18 Oct 2013 02:45am EDT 

Valneva SE announced that the United States Food and Drug Administration's (FDA) office of Orphan Drug Development (OOPD) granted a seven years orphan drug market exclusivity period for IXIARO for prevention of disease caused by Japanese Encephalitis (JE) virus in children two months to less than 17 years of age. During this seven-year exclusivity period, the FDA will not approve another vaccine for the prevention of JE in children less than 17 years of age, unless such competitive JE vaccine can be shown to be clinically superior to IXIARO in this pediatric population. The seven-year exclusivity period began on May 17, 2013, which coincides with the date of FDA's approval of the pediatric indication for IXIARO. 

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