The FDA has approved the use of a transcutaneous electrical nerve stimulation device (Cefaly – Cefaly Technology) for prevention of episodic migraine in patients ≥18 years old. The first device to be approved in the US for migraine prevention, it is available in Canada and Europe for treatment and prevention of migraines. A transcranial magnetic stimulation device (SpringTMS - eNeura Therapeutics) recently approved by the FDA for treatment of migraine preceded by aura will be reviewed in a future issue.

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...

Panitumumab (Vectibix - Amgen), a fully human IgG₂ monoclonal antibody that inhibits the epidermal growth factor receptor (EGFR), has been approved by the FDA for treatment of patients with EGFR-expressing metastatic colorectal cancer that has progressed despite standard chemotherapy. It is the second monoclonal antibody EGFR inhibitor to be approved for metastatic colorectal cancer; cetuximab (Erbitux), a human-murine chimeric IgG₁ monoclonal antibody, was approved in 2004.

The FDA has approved the marketing of certolizumab pegol (Cimzia - UCB), a tumor necrosis factor (TNF) blocker, for treatment of moderate to severe Crohn's disease refractory to conventional treatment. It is the third TNF blocker approved for this indication.

The FDA has approved ibrexafungerp (Brexafemme – Scynexis), a first-in-class triterpenoid antifungal ("fungerp"), for oral treatment of vulvovaginal candidiasis in postmenarchal females.

The FDA has approved a fixed-dose combination of the amide local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam as an extended-release (ER) solution (Zynrelef – Heron) for single-dose, intraoperative, soft-tissue or periarticular instillation to provide postsurgical analgesia for up to 72 hours in adults undergoing foot and ankle, small-to-medium open abdominal, or lower extremity total joint arthroplasty surgical procedures.

The injectable glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide, which was approved by the FDA as Mounjaro for treatment of type 2 diabetes in 2022, has now been approved as Zepbound (Lilly) for chronic weight management in adults who have a BMI ≥30 kg/m2 or a BMI ≥27 kg/m2 and at least one weight-related comorbidity. The injectable GLP-1 receptor agonists liraglutide (Saxenda) and semaglutide (Wegovy) are approved for chronic weight management in patients ≥12 years...

Ketoconazole (Nizoral - Janssen), an imidazole antifungal drug widely used in a tablet formulation for treatment of systemic fungal infections (Medical Letter 36:16, 1994) and as a topical preparation for fungal skin infections, is also available as a shampoo for treatment of seborrheic dandruff. The shampoo is sold only by prescription.

Cysteamine bitartrate (Cystagon - Mylan), an orphan drug, has been approved by the US Food and Drug Administration for oral treatment of nephropathic cystinosis, an autosomal recessive metabolic disorder that affects only a few hundred people in the USA (WA Gahl et al, in The Metabolic Basis of Inherited Disease, 7th ed., CR Scriver et al, eds, New York:McGraw-Hill, 1995, p 3763).

The FDA has approved ipilimumab (Yervoy – Bristol-Myers Squibb), a recombinant human monoclonal antibody, for treatment of unresectable or metastatic melanoma.