Ertapenem (er ta pen' em; Invanz - Merck), a carbapenem antibacterial with a narrower spectrum of activity than imipenem (Primaxin) or meropenem (Merrem), has been approved by the FDA for once-daily IV treatment of complicated intra-abdominal, urinary tract and skin and skin structure infections, acute pelvic infections, and community-acquired pneumonia.

Cefmetazole sodium (Zefazone - Upjohn), a second-generation parenteral cephalosporin, was recently marketed in the USA for intravenous (IV) treatment of various infections caused by susceptible organisms. Like cefotetan (Cefotan), cefamandole (Mandol), cefoperazone (Cefobid), and moxalactam (Moxam), cefmetazole contains a methylthiotetrazole group that has been associated with prothrombin deficiency.

The FDA has approved a fixed-dose combination (Harvoni [har voe' nee] – Gilead) of sofosbuvir and ledipasvir (led' i pas' vir), two oral direct-acting antiviral agents, for treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Genotype 1 is responsible for 70-80% of HCV infections in the US. Sofosbuvir (Sovaldi) was approved earlier for use in combination with other antiviral drugs for treatment of HCV infection. Ledipasvir is a new drug.

The CDC recently announced that it will now supply the investigational drug miltefosine (Impavido – Paladin, Canada) for treatment of infections caused by free-living amebae.1 The drug was previously available in the US only from the manufacturer through an FDA Investigational New Drug (IND) application.Meningoencephalitis caused by the free-living amebae Naegleria fowleri, Acanthamoeba spp., or Balamuthia mandrillaris, usually acquired through the nose while swimming in warm fresh water, has a mortality rate of >90% despite treatment with multiple antimicrobial drugs.2 Miltefosine is...

Ofloxacin (Floxin - McNeil, Ortho), a new fluoroquinolone antibacterial agent, was recently marketed in the USA for oral treatment of various infections caused by susceptible microorganisms. Ofloxacin is the third fluoroquinolone to become available in this country. Norfloxacin (Noroxin - Medical Letter, 29:25, 1987) is marketed only for treatment of urinary tract infections. Ciprofloxacin (Cipro - Medical Letter, 30:11, 1988), like ofloxacin, is approved for use in a variety of infections.

Diagnostic tests for human immunodeficiency virus (HIV) infection use four approaches: identification of antibodies to viral proteins, detection of viral antigens, detection of viral nucleic acids, and culturing the virus (CJ Schleupner in GL Mandell et al, eds, Principles and Practice of Infectious Diseases, 4th ed, New York:Churchill Livingstone, 1995, page 1253). In recent years, the FDA has approved the use of a 10- minute blood test, two home collection kits, and office tests that use urine and oral secretions to diagnose HIV infection. One home test, Confide (Johnson & Johnson), was...

The FDA has approved Rebyota (Ferring), a rectally-administered, live fecal microbiota suspension, for prevention of additional recurrences of Clostridioides difficile infection (CDI) following antibiotic treatment for a recurrent episode of CDI in adults. Rebyota is the first microbiome-based treatment to be approved for this indication. It is not approved for initial treatment of CDI. Fecal microbiota transplantation (FMT) has been used in patients with multiple CDI recurrences.

Ceftobiprole medocaril sodium (Zevtera – Innoviva Specialty Therapeutics), a new IV cephalosporin antibacterial drug, has been approved by the FDA for treatment of Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSIs), and community-acquired bacterial pneumonia (CABP) (see Table 1). It is the second cephalosporin with activity against methicillin-resistant S. aureus (MRSA) to be approved in the US; ceftaroline (Teflaro), which was approved for treatment of ABSSSIs and CABP in 2010, was the...

Temafloxacin (Omniflox - Abbott) and lomefloxacin (Maxaquin - Searle) are the latest fluoroquinolone antimicrobial agents to be approved by the US Food and Drug Administration (FDA) for oral treatment of various infections. Previously marketed include norfloxacin (Noroxin - Medical Letter, 29:25, 1987), ciprofloxacin (Cipro - Medical Letter, 30:11, 1988), and ofloxacin (Floxin - Medical Letter, 33:71, 1991). Norfloxacin is marketed only for treatment of urinary tract infections, and lomefloxacin only for treatment of urinary tract infections and bronchitis known to be caused by...

Linezolid, the first of a new class of antibiotics, the oxazolidinones, has been marketed for treatment of infection due to vancomycin-resistant Enterococcus faecium, nosocomial and community-acquired pueumonia due to Staphylococcus aureus or penicillin-sucsceptible Streptococcus pneumoniae, and skin and skin structure infections, including those due to methicillin-resistant S. aureus (MRSA).