The FDA has approved a 1% cream formulation of ozenoxacin (Xepi – Cutanea), a nonfluorinated quinolone antibiotic, for treatment of impetigo caused by Staphylococcus aureus or Streptococcus pyogenes in patients ≥2 months old.

Sparfloxacin (Zagam - Rh ne-Poulenc Rorer) and levofloxacin (Levaquin - Ortho-McNeil) are the newest fluoroquinolone antimicrobials to be approved by the US Food and Drug Administration. Sparfloxacin in a once-daily oral preparation is being marketed for treatment of community-acquired pneumonia and acute bacterial exacerbations of chronic bronchitis. Levofloxacin, which is the active stereoisomer of ofloxacin (Floxin), is available for either oral or parenteral use; it is approved for oncedaily treatment of community-acquired pneumonia, acute exacerbations of chronic bronchitis,...

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.

The FDA has issued new warnings about the use of the opioid analgesics codeine and tramadol in children, particularly those <12 years old, and in breastfeeding women due to concerns about the risk of respiratory depression and death. The FDA previously issued warnings about these drugs in 2013 and 2015.

A Medical Letter reader has asked us to review the safety of the fluoroquinolone antibiotic levofloxacin (Levaquin – Ortho-McNeil-Janssen), which has just been approved for generic use by the FDA and has been at the center of some recent lawsuits regarding the adequacy of its safety warnings.

Palopegteriparatide (Yorvipath – Ascendis), a parathyroid hormone (PTH) 1-34 analog, has been approved by the FDA for treatment of hypoparathyroidism in adults. The parathyroid hormone analog teriparatide (Forteo, and others), which is approved for treatment of postmenopausal osteoporosis, has been used off-label for treatment of hypoparathyroidism.

The FDA has approved a progestin-only oral contraceptive ("minipill") containing drospirenone (Slynd – Exeltis). All other progestin-only oral contraceptives available in the US contain norethindrone (Camila, and others). Progestin-only oral contraceptives are similar in efficacy to combination oral contraceptives. They are used predominantly by breastfeeding women and by those in whom estrogen is poorly tolerated or contraindicated. Combination oral contraceptives containing drospirenone and ethinyl estradiol have been available for years.

Rifapentine, a long-acting analog of rifampin developed in the 1960's, has received an accelerated approval from the FDA for oral use, with at least one other drug, in the treatment of pulmonary tuberculosis.

The FDA has approved omadacycline (Nuzyra – Paratek), a semisynthetic tetracycline derivative, for once-daily IV and oral treatment of community-acquired bacterial pneumonia (CAP) and acute bacterial skin and skin structure infections (ABSSSIs) in adults.

Cefixime (Suprax - Lederle), an oral cephalosporin antibiotic, was recently approved for marketing by the US Food and Drug Administration. Claimed to be the first oral third-generation cephalosporin, the new drug is offered for once-a-day treatment of otitis media, pharyngitis, bronchitis and urinary tract infections.