Pramipexole (Mirapex - Pharmacia & Upjohn) and ropinirole (Requip - SmithKline Beecham), two new dopamine agonists, have been approved by the US Food and Drug Administration (FDA) for treatment of both early (without levodopa) and advanced (with levodopa) Parkinson's disease. Bromocriptine (Parlodel) and pergolide (Permax) are older dopamine agonists marketed in the USA for adjunctive use with levodopa.

Cerivastatin (Baycol - Bayer), a new HMG-CoA reductase inhibitor (or "statin"), has been approved by the FDA for treatment of hypercholesterolemia. Cerivastatin is the sodium salt of a synthetic fluorophenyl pyridinyl-substituted heptanoic acid.

Dofetilide (Tikosyn - Pfizer), a new methanesulfonamide antiarrhythmic drug, has recently been marketed for oral treatment of atrial fibrillation and flutter.

Fulvestrant (Faslodex -- AstraZeneca), an estrogen receptor antagonist given intramuscularly (IM) once a month, was recently approved by the FDA for treatment of hormone-receptor-positive metastatic breast cancer in postmenopausal women with disease progession on tamoxifen (Nolvadex, and others) or another antiestrogen.

Vardenafil (Levitra -Bayer) is the second oral drug approved by the FDA for treatment of erectile dysfunction. Sildenafil (Viagra - Medical Letter 1998; 40:51), the first oral drug, has been available for 5 years. Pharmacokinetics, effectiveness, adverse effects, dosage and cost of the new drug are reviewed. Whether it offers any benefits over sildenafil is discussed.

Alfuzosin hydrochloride (Uroxatral - Sanofi-Synthelabo) is now available in the US in a new formulation for once-daily treatment of benign prostatic hyperplasia (BPH). The drug has been used in Europe since 1987. Alpha₁-blockers cause relaxation of smooth muscle tone in the bladder neck, prostatic capsule and prostatic urethra, relieving symptoms of urinary obstruction.

Levodopa combined with carbidopa (Sinemet, and others) is the most widely used treatment for patients with Parkinson's disease, but after 2 to 5 years most patients develop troublesome complications (Treatment Guidelines from The Medical Letter 2004; 2:41). The newest treatment for Parkinson's disease patients with end-of-dose "wearing-off" is Stalevo (Novartis), a combination of the catechol-O-methyltransferase (COMT) inhibitor entacapone (Comtan) with 3 different doses of levodopa/carbidopa. The rationale for Stalevo is that it permits some patients to take only one pill rather than...

The FDA has approved a new low-dose estrogen patch (Menostar - Berlex) for prevention of osteoporosis in postmenopausal women. Unlike other estrogen patches, it is not approved for treatment of hot flashes or other menopausal symptoms. Promotional material from the manufacturer suggests that this low dose of estrogen could prevent osteoporosis without some of the adverse effects of higher doses.

Entecavir (Baraclude - Bristol-Myers Squibb), a nucleoside analog, has been approved by the FDA for treatment of adults with active chronic hepatitis B virus (HBV) infection.

Deferasirox (Exjade - Novartis), an oral chelating agent, recently received accelerated approval from the FDA as an orphan drug for oral treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients >2 years old. Deferasirox is a tridentate (2 molecules of deferasirox bind to one atom of iron) chelating agent with high affinity for iron. It has much lower affinity for zinc and copper.