Paratek caps 20-year R&D jour­ney with FDA OK for its broad spec­trum an­tibi­ot­ic — time to talk launch

Paratek has bagged its first — and sec­ond — FDA OK for its an­tibi­otics on the same day.

The big ap­proval, 20 years in the mak­ing, goes to omada­cy­cline — dubbed Nuzyra — for both com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia (CABP) and acute skin and skin struc­ture in­fec­tions (AB­SS­SI).

Ear­li­er, reg­u­la­tors al­so gave a green light for sare­cy­cline to treat a mod­er­ate to se­vere form of ac­ne. Hav­ing out-li­censed the drug years ago, Paratek still stands to re­ceive $12 mil­lion in mile­stone pay­ments and roy­al­ties up­on com­mer­cial­iza­tion.

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