Table 2. Main characteristics of the described antibacterial drugs FDA approved in 201936-49.
Food and Drug Administration (FDA), European Medicines Agency (EMA), complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs), community-acquired bacterial pneumonia (CABP), intravenous (IV), oral administration/per oral (PO), hours (h); doses and duration have to be verified in the most recent prescriptions reglementations, according to the local laws before administration
| NAME (generic/brand/ class) | Approval status | Indication | Administration | Dose and duration |
|---|---|---|---|---|
| Imipenem, cilastatin, relebactam (Recarbrio) COMPANY: Merck & Co (NJ, USA) | FDA: approved in July 2019 EMA: not yet approved | cUTI, cIAI | IV infusion | Injection, powder for reconstitution 500mg/500mg/250mg per vial (ie, 1.25g/vial) A. Urinary Tract Infection: 1.25 g IV every 6h x 4-14 days B. Intra-abdominal Infections 1.25 g IV every 6h x 4-14 days |
| Pretomanid / nitroimidazole, a class of novel anti-bacterial agents, in combination with bedaquiline and linezolid COMPANY: TB Alliance (NY, USA & South Africa; non-profit) | FDA: approved in August 2019 EMA: not yet approved | Drug-resistant TB (lung tuberculosis) | PO, one tablet (200ml, adult) taken once a day for 26 weeks | Pretomanid 200 mg PO/day x 26 weeks Bedaquiline 400 mg PO/day x 2 weeks, Then, 200 mg 3x/week with at least 48 h between doses for x 24 weeks (total of 26 weeks) Linezolid 1200 mg PO/day for 26 weeks |
| Lefamulin (Xenleta) / semisynthetic pleuromutilin antibiotic COMPANY: Nabriva Therapeutics (Ireland) | FDA: approved in August 2019 EMA: not yet approved | CABP | IV and PO treatment | 600 mg orally every 12 hours for 5 days or 150 mg infused IV over 60 minutes every 12 hours for 5-7 days; IV: -Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended. -Severe liver dysfunction (Child-Pugh C): 150 mg IV every 24 hours Oral: -Mild liver dysfunction (Child-Pugh A): No adjustment recommended. -Moderate or severe liver dysfunction (Child-Pugh B or C): Not recommended. |
| Cefiderocol (Fetroja) / cephalosporin antibacterial COMPANY: Shionogi & Co., Ltd. (Japan) | FDA: approved in November 2019 EMA: not yet approved | cUTI | IV | 2 gram IV every 8h for 7-14 days |