Paratek clears one last big hur­dle on the way to an FDA mar­ket­ing de­ci­sion for an­tibi­ot­ic

Paratek’s $PRTK an­tibi­ot­ic omada­cy­cline went three for three in Phase III. And now it looks ready to move on to a near-term FDA ap­proval.

An agency ex­pert pan­el pro­vid­ed its bless­ing for a mar­ket­ing ap­proval on Wednes­day, vot­ing 17-to-1 to rec­om­mend it for acute bac­te­r­i­al skin and skin struc­ture in­fec­tions with a still-lop­sided 14-to-4 vote fa­vor­ing an OK for com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia.

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