Venlafaxine hydrochloride (Effexor - Wyeth-Ayerst) was recently approved by the US Food and Drug Administration for treatment of depression. An aminomethyl-benzyl- cyclohexanol, it is chemically related to bupropion (Wellbutrin).

Tacrolimus (Prograf - Fujisawa), previously called FK506 (Medical Letter, 33:94, 1991), has been approved by the US Food and Drug Administration for primary prevention of organ rejection in patients receiving liver transplants. The drug has also been used as rescue therapy for organ graft rejection unresponsive to cyclosporine (Sandimmune) and other immunosuppressive drugs.

Fluvoxamine (Luvox - Solvay), a selective serotonin reuptake inhibitor (SSRI), has been approved for treatment of obsessive-compulsive disorder (OCD) by the US Food and Drug Administration. Fluoxetine (Prozac), another SSRI antidepressant, and clomipramine (Anafranil), a tricyclic antidepressant that also inhibits serotonin reuptake, are the only other drugs available for this indication in the USA. Antidepressants that do not inhibit serotonin reuptake have not been effective for treatment of this condition.

A vaccine to prevent hepatitis A (Havrix - SmithKline Beecham), previously licensed in more than 40 countries, including Canada, is now available in the United States. A similar vaccine manufactured by Merck is investigational in the USA.

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.

Lansoprazole (Prevacid -TAP), a proton pump inhibitor similar to omeprazole (Prilosec - Medical Letter, 32:19, 1990), has been approved by the US Food and Drug Administration for short-term treatment of active duodenal ulcer and erosive reflux esophagitis and for long-term treatment of chronic hypersecretory conditions, including the Zollinger-Ellison syndrome.

Several readers have asked the Medical Letter to evaluate the effectiveness and safety of exogenous melatonin for treatment of insomnia and jet lag. Melatonin has not been approved by the US Food and Drug Administration (FDA), but is available in health food stores and apparently is being used as self-medication to treat a wide variety of disorders.

An intravenous formulation of amiodarone (Cordarone IV -Wyeth-Ayerst) has been approved by the US Food and Drug Administration (FDA) for treatment and prophylaxis of recurrent ventricular fibrillation (VF) or hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy.

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.

An inhalation aerosol formulation of the corticosteroid fluticasone propionate (Flovent -Glaxo Wellcome) has been approved by the US Food and Drug Administration for maintenance treatment of asthma.