FDA approves Basilea’s antibiotic for severe bacterial infections

The FDA on Wednes­day ap­proved Basilea’s an­tibi­ot­ic Zevtera to treat three con­di­tions: staph in­fec­tions, acute bac­te­r­i­al skin and skin struc­ture in­fec­tions, and com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia.

For com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia, the ap­proval in­cludes adults and pe­di­atric pa­tients old­er than 3 months.

The ap­pli­ca­tion for Zevtera, which is al­so known as cefto­bip­ro­le, was de­layed af­ter the com­pa­ny an­nounced it would push back its NDA plans last year due to man­u­fac­tur­ing is­sues. At that time, Basilea said the de­lay wasn’t re­lat­ed to the man­u­fac­tur­ing process or to the qual­i­ty or safe­ty of cefto­bip­ro­le. It in­stead cit­ed a need to up­date the “qual­i­ty sys­tem” of the con­tract man­u­fac­tur­ing or­ga­ni­za­tion dur­ing prepa­ra­tions for FDA in­spec­tions.

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