Sotalol (hydrochloride (Betapace -Berlex; Sotacor -Bristol Laboratories of Canada), an antiarrhythmic drug that prolongs repolarization (Class III) and also has beta-adrenergic-blocking activity (Class II), was recently approved by the US Food and Drug Administration (FDA) for oral treatment of life-threatening ventricular arrhythmias.

Zolpidem (Ambien - Searle), an imidazopyridine hypnotic available in Europe for several years, was recently approved by the US Food and Drug Administration for short-term treatment of insomnia.

Isosorbide mononitrate, the major active metabolite of isosorbide dinitrate, was first approved in the USA for oral use in patients with chronic stable angina in 1992 (Medical Letter, 34:61, 1992). Now an extended-release formulation of isosorbide mononitrate (Imdur -Key) has been approved by the US Food and Drug Administration.

Fluvastatin (Lescol - Sandoz), an HMG-CoA reductase inhibitor, was recently marketed in the USA for treatment of hypercholesterolemia. A synthetic mevalonolactone derivative, it is chemically distinct from previously available drugs in this class.

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).

Modafinil (Provigil), a benzhydryl sulfinylacetamide non-amphetamine stimulant that has been used in Europe since 1995, has now been approved by the FDA for treatment of excessive daytime sleepiness associated with narcolepsy.

Rebetron, a combination of injected recombinant interferon alfa-2b with oral ribavirin has been approved by the FDA for treatment of chronic hepatitis C virus infection.

Entacapone (Comtan), a catechol-O-methyltransferase (COMT) inhibitor, has been approved by the FDA for adjunctive use with levodopa/carbidopa in patients with Parkinson's disease who have end-of-dose "wearing off"symptoms.

Fluoxetine, a selective serotonin reuptake inhibitor (SSRI) previously sold only as Prozac, is now also marketed as Sarafem for treatment of premenstrual dysphoric disorder (PMDD). Generic fluoxetine is expected to be available sometime this year.

The FDA had approved an intrauterine contraceptive device that releases the synthetic progestin levonorgestrel over a period of five years. The device has been available in Europe for 10 years.