FDA hands a CRL to drug­mak­er Eton af­ter a de­layed in­spec­tion — but are Covid-19 trav­el re­stric­tions re­al­ly the is­sue?

For the sec­ond time in three years, Eton Phar­ma­ceu­ti­cals has re­ceived a com­plete re­sponse let­ter from the FDA, this time for its de­hy­drat­ed al­co­hol in­jec­tion to treat methanol poi­son­ing. The com­pa­ny blamed the de­lay on a miss­ing in­spec­tion but al­so point­ed to “oth­er ques­tions” from the agency.

On Fri­day, Eton dis­closed it had re­ceived a let­ter from the agency, ty­ing it to a pend­ing pre-ap­proval in­spec­tion of its Eu­ro­pean man­u­fac­tur­er due to Covid-re­lat­ed trav­el re­stric­tions. But it’s worth not­ing that the FDA doesn’t is­sue CRLs based sole­ly on in­spec­tion de­lays, an agency spokesman pre­vi­ous­ly told End­points News, in­di­cat­ing there may have been oth­er is­sues with Eton’s ap­pli­ca­tion.

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