Vi­a­tris pe­ti­tions FDA over would-be EpiPen com­peti­tor, claim­ing more da­ta nec­es­sary

Vi­a­tris, over the last two years, pulled in more than $750 mil­lion from its EpiPen au­toin­jec­tor, a key emer­gency treat­ment for ana­phy­lax­is. So it should be no sur­prise that the gener­ics com­pa­ny (a com­bi­na­tion of My­lan and Pfiz­er’s Up­john) on Mon­day filed a Cit­i­zen Pe­ti­tion with the FDA, call­ing on ARS Phar­ma­ceu­ti­cals to run ad­di­tion­al PK/PD stud­ies be­fore the com­pa­ny can win ap­proval for the coun­try’s first ep­i­neph­rine nasal spray.

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