Sermorelin acetate, a synthetic form of human growth-hormone-releasing factor has been approved by the FDA for treatment of idiopathic growth hormone deficiency in children with growth failure.

PC Spes, a dietary supplement sold for "prostate health", is being used increasingly to treat prostate cancer.

Azelaic acid 15% gel (Finacea Berlex) is now available in the US for treatment of mild to moderate rosacea. A 20% cream formulation of the drug (Azelex Allergan; Medical Letter 1996; 38:52) has been marketed here since 1996 for treatment of acne. The effectiveness of Finacea compared to its own vehicle and to metronidazole gel is discussed. Information on the drug's mechanism of action, adverse effects, dosage and cost are also included.

The FDA has approved a lingual aerosol formulation of nitroglycerin (NitroMist – Akrimax) for acute relief of an attack or acute prophylaxis of angina pectoris. It is the second nitroglycerin lingual spray to become available in the US; Nitrolingual Pumpspray was approved in 1985. Most patients with angina use sublingual nitroglycerin tablets.

The FDA has approved the use of the phosphodiesterase-5 (PDE-5) inhibitor tadalafil (Cialis – Lilly) for treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in men with or without erectile dysfunction. Tadalafil is approved for use under another brand name (Adcirca) for treatment of pulmonary arterial hypertension. The other PDE-5 inhibitors available in the US for treatment of erectile dysfunction (sildenafil [Viagra]; vardenafil [Levitra]) have also been reported to be effective for treatment of BPH signs and symptoms, but have not been approved for this...

HA-1A (Centoxin - Centocor), a monoclonal IgM antibody against endotoxin from gram-negative bacteria, may soon be approved for marketing by the US Food and Drug Administration. Commercially available in Europe, HA-1A has been used in the USA as an investigational drug. E5 (Xomen - Xoma), another monoclonal IgM antibody against endotoxin, is also available here for investigational use.

Nisoldipine (Sular -Zeneca), a dihydropyridine calcium-channel blocker structurally similar to nifedipine, has been approved for marketing by the US Food and Drug Administration. It is available in an oral extended-release formulation for treatment of hypertension.

Sildenafil citrate (Viagra - Pfizer) is the first oral drug approved by the FDA for treatment of erectile dysfunction. Alprostadil is also marketed for this indication but must be injected into the corpus cavemosum (Caverject) or pushed into the urethra (MUSE).

Risedronate (Actonel - Procter & Gamble), a pyridinyl bisphosphonate, has been approved by the FDA for oral treatment of Paget's disease of bone. Characterized by excessive bone resorption, bony deformity, disorganized bone remodeling and structural weakness, Paget's disease occurs in up to 3% of people older than 55 in Europe and North America (PD Delmas and PJ Meunier, N Engl J Med, 336:558, 1997).

Infliximab, a monoclonal antibody that inhibits tumor necrosis factor, has received an accelerated approval from the FDA for intravenous treatment of moderate to severe Crohn's disease refractory to other medical treatment.