NAME (generic/brand/ class) |
Approval status |
Indication |
Administration |
Dose and duration |
Plazomicin (Zemdri)/ aminoglycoside antibiotic COMPANY: Achaogen, Inc. (CA, USA) |
FDA: approved in June 2018
EMA: application submitted (2018) |
cUTIs; Enterobacteriaceae infections |
IV infusion, every 24 hours for 4-7 days. |
A. Dosage regimen (adults with CrCl>60ml/min): 15 mg/kg every 24 hours
B. Dosage regimen (adults with CrCl>30 <60 ml/min): 10 mg/kg every 24h
C. Dosage regimen (adults with CrCl>15 <30 ml/min): 10 mg/kg every 48h |
Eravacycline (Xerava) / fully synthetic fluorocycline COMPANY: Tetraphase Pharmaceutical (MA, USA) |
FDA: approved in August 2018
EMA: approved in September 2018 |
cIAI |
IV 60 min infusion, given once every 12 hours for a total of 4 to 14 days; dose is patient’s weight dependent |
Adult patients (≥18 years of age) with cIAI: administer 1mg/kg, every 12h, by IV infusion (~ 60min); recommended duration of treatment is 4 to 14 days |
Sarecycline (Seysara) / tetracycline-derived antibiotic COMPANY: Paratek Pharmaceuticals (MA, USA) and Allergan plc (USA) – acquired by Almirall SA (Spain) |
FDA: approved in October 2018
EMA: not yet approved |
non-nodular moderate to severe acne |
PO administration with food |
A. Adult
<54 kg: 60 mg PO every Day 55-84 kg: 100 mg PO every Day 85-136 kg: 150 mg PO every Day
B. Children ≥9 years
33-54 kg: 60 mg PO every Day 55-84 kg: 100 mg PO every Day 85-136 kg: 150 mg PO every Day
If improvement after 12 weeks not observed, reassess treatment |
Omadacycline (Nuzyra) / aminomethylcycline antibiotic, tetracycline class (inhibits 30S ribosomal subunit) COMPANY: Paratek Pharmaceuticals (MA, USA) |
FDA: approved in October 2018
EMA: not yet approved |
CABP, ABSSSI |
Both once-daily IV and PO formulations |
A. For patients with CABP, the loading dose on day 1 is 200 mg by IV infusion over 60 minutes, or 100 mg by IV infusion over 30 minutes, given twice; the maintenance dose is 100 mg by IV infusion over 30 minutes once daily, or 300 mg PO daily for a total of 7 to 14 days.
B. For patients with ABSSSI, the loading dose on day 1 is 200 mg by IV infusion over 60 minutes; or 100 mg by IV infusion over 30 minutes, given twice; or, on days 1 and 2, 450 mg orally once daily. The maintenance dose is 100 mg by IV infusion over 30 minutes once daily, or 300 mg PO daily, for a total duration of 7 to 14 days |
Rifamycin (Aemcolo) / bactericidal; inhibit bacterial DNA-dependent RNA polymerase, suppressing RNA synthesis COMPANY: Cosmo Pharmaceuticals (Ireland) |
FDA: approved in November 2018 EMA: not yet approved |
Travelers' diarrhea (noninvasive strains (E. coli) |
PO administration |
388 mg (2 tablets) PO twice a day x 3 days |