Posted by Michael Wonder on 04 Apr 2018
Paratek’s new drug applications for oral and intravenous omadacycline accepted for priority review by FDA
4 April 2018 - PDUFA action date in October 2018.
Paratek Pharmaceuticals announced today that the U.S. FDA has accepted the new drug applications and granted a priority review for omadacycline, an investigational once-daily oral and intravenous broad spectrum antibiotic. Paratek is seeking approval of omadacycline, a modernized tetracycline, for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
The two applications were granted priority review based on the significant unmet medical need for new agents to treat ABSSSI and CABP. In addition to priority review, omadacycline has previously been granted qualified infectious disease product and Fast Track designations for the treatment of CABP and ABSSSI.
