Belzutifan (Welireg – Merck), a first-in-class hypoxia-inducible factor inhibitor, has been approved by the FDA for treatment of advanced renal cell carcinoma (RCC) in adults who received prior treatment with a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). Belzutifan was previously approved for use in patients with von Hippel-Lindau disease.

Monoclate (Armour), a formulation of Factor VIII (antihemophilic factor; AHF) prepared by immunoaffinity chromatography, was recently approved for marketing by the US Food and Drug Administration. The new product is claimed to be more highly purified than older AHF formulations. Factor VIII concentrates commercially available in the USA are listed in the table below.

Nafarelin acetate (Synarel - Syntex), a synthetic analog of gonadotropin-releasing hormone (GnRH), was recently approved by the US Food and Drug Administration for treatment of endometriosis. The drug is available only in a nasal spray formulation.

Self-injection of papaverine, a smooth muscle relaxant, and phentolamine (Regitine), an alpha-adrenergic blocker, directly into the corpus cavernosum has been effective for treatment of impotence in some patients, even after complete quadriplegia, radical surgery for bladder or prostate cancer, or castration (Medical Letter, 29:95, 1987). Recently, injections of prostaglandin E1, now called alprostadil (Prostin VR - Upjohn), have also been tried for this purpose. No drug is approved for this use by the US Food and Drug Administration.

Tramadol hydrochloride (Ultram - Ortho-McNeil), a centrally-acting analgesic marketed in Germany since 1977, was recently approved by the US Food and Drug Administration for oral treatment of moderate to moderately severe pain. Despite some opioid activity, tramadol has not been scheduled as a controlled substance.

Micronized fenofibrate (Tricor - Abbott), a fibric acid derivative structurally similar to clofibrate (Atromid-S, and others) and gemfibrozil (Lopid, and others), has been approved by the FDA for treatment of hypertriglyceridemia. Increased serum triglyceride concentrations have been associated with an increased risk of coronary heart disease (J Jeppesen et al, Circulation, 97:1029, 1998).

Creatine, a natural amino acid derivative, and androstenedione, a testosterone precursor, are marketed as 'dietary supplements' in health food stores and are widely believed to enhance athletic performance. Both have been in the news recently because Mark McGwire, the baseball home-run record-setter, reportedly has said he takes both. Neither has been approved for any indication by the US Food and Drug Administration (FDA).

Zoledronic acid (Zometa), a new bisphosphonate, has been approved by the FDA for intravenous (IV) treatment of hypercalcemia of malignancy.

Most angioplasty procedures for coronary artery disease now include placement of stents, which have improved both short- and long-term success rates. The main limitation is restenosis, which occurs in about 25% of patients. Drug-eluting stents intended to reduce the incidence of restenosis have been approved for use in Europe, but not yet in the US.

Cinacalcet hydrochloride (Sensipar - Amgen) has been approved by the FDA for treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis and treatment of hypercalcemia in patients with parathyroid carcinoma.