The FDA has approved a topical 8% patch formulation of capsaicin (Qutenza – NeurogesX), available only by prescription, for local treatment of postherpetic neuralgia. Postherpetic neuralgia occurs after herpes zoster in about one third of patients ≥60 years old and can persist for months or even years.

The angiotensin receptor blocker (ARB) azilsartan medoxomil (Edarbi – Takeda) was recently approved by the FDA for oral treatment of hypertension, either alone or combined with other drugs. It is the eighth ARB approved for this indication.

The FDA has approved a fixed-dose combination of the angiotensin receptor blocker (ARB) azilsartan and the thiazide-like diuretic chlorthalidone as Edarbyclor (Takeda) for treatment of hypertension

The FDA has approved setmelanotide (Imcivree – Rhythm), a subcutaneously injected melanocortin 4 (MC4) receptor agonist, for chronic weight management in patients ≥6 years old with obesity due to pro-opiomelanocortin (POMC) deficiency, proprotein subtilisin/kexin type 1 (PCSK1) deficiency, or leptin receptor (LEPR) deficiency.

The oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) has been approved by the FDA for use in combination with capecitabine (Xeloda, and generics) for treatment of advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who received ≥2 prior anti-HER2-based regimens for metastatic disease. It was previously approved for use as monotherapy for extended adjuvant treatment of adults with early-stage, HER2-positive breast cancer following adjuvant trastuzumab (Herceptin)-based therapy. HER2 is overexpressed in...

The oral kinase inhibitor tucatinib (Tukysa – Seagen) has received accelerated approval from the FDA for use in combination with trastuzumab (Herceptin) for treatment of adults with RAS wild-type human epidermal growth factor receptor 2 (HER2)-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimens. Tucatinib was approved in 2020 for use in combination with trastuzumab and capecitabine (Xeloda, and generics) for treatment of adults with advanced unresectable or...

Axatilimab-csfr (Niktimvo – Incyte), a colony stimulating factor-1 receptor-blocking antibody, has been approved by the FDA for intravenous treatment of chronic graft-versus-host disease (cGVHD) after failure of at least 2 lines of systemic therapy in patients weighing ≥40 kg. Corticosteroids are generally the first-line treatment for cGVHD. The oral kinase inhibitors ibrutinib (Imbruvica), ruxolitinib (Jakafi), and belumosudil (Rezurock) are also approved for treatment of cGVHD. Extracorporeal photopheresis has been used off-label.

An ophthalmic formulation of ciprofloxacin hydrochloride (Ciloxan - Alcon), a fluoroquinolone antibiotic, was recently marketed in the USA for treatment of bacterial keratitis and conjunctivitis. Ciprofloxacin has been used orally (Cipro) to treat a variety of serious infections (Medical Letter, 30:11, 1988) and recently was approved for intravenous administration.

Advertisements for clemastine (Tavist-1 - Sandoz), an ethanolamine oral antihistamine, have recently appeared on television and in major newspapers in the USA. Clemastine is an old drug (Medical Letter, 21:24, 1979) that has now become available without a prescription.

Drotrecogin alfa (activated) (Xigris - Lilly), recombinant human activated protein C, has been approved by the FDA for treatment, in combination with standard therapy, of critically ill adults with severe sepsis and a high risk of death.