FDA approves Paratek antibiotics

Paratek Pharmaceuticals Inc. (NASDAQ:PRTK) received a pair of FDA approvals Oct. 2 for Nuzyra omadacycline and Seysara sarecycline. The agency approved Nuzyra to treat community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSIs). Seysara was approved in inflammatory lesions of non-nodular moderate to severe acne vulgaris.

Paratek said Nuzyra, an aminomethylcycline antibiotic that is designed to overcome tetracycline resistance, is the first once-daily IV and oral antibiotic approved to treat both indications in almost 20 years. Its label includes language noting an imbalance of mortality compared with moxifloxacin...