FDA re­jects Nabri­va a sec­ond time; Nabri­va pins it on trav­el re­stric­tions

A lit­tle over a year af­ter the FDA is­sued Nabri­va its first CRL for the an­tibi­ot­ic Con­tepo, the agency has is­sued an­oth­er.

By Nabri­va’s ac­count, the agency’s rea­son­ing hasn’t changed. They again cit­ed un­re­solved man­u­fac­tur­ing is­sues at the com­pa­ny’s CMO fa­cil­i­ties in Eu­rope and asked for no new clin­i­cal da­ta. The prob­lem, Nabri­va said, was that be­cause of trav­el re­stric­tions, the agency wasn’t able to do an on­site in­spec­tion of the fa­cil­i­ties to con­firm that the is­sues raised last year had been fixed.

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