hydrochloride (Ticlid - Syntex), a platelet aggregation inhibitor that has been available in Europe for more than a decade, was recently approved by the U.S. Food and Drug Administration to decrease the risk of thrombotic stroke in men and women who have had premonitory signs of stroke or have had a completed thrombotic stroke. The manufacturer is promoting the drug for patients intolerant to aspirin or with conditions for which aspirin has not been approved (previous thrombotic stroke; transient ischemic attacks in women). The drug has also been used for prevention of myocardial ...

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.

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.

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).

Citalopram hydrobromide (Celexa - Forest/Parke-Davis), a selective serotonin reuptake inhibitor (SSRI) available in Europe since 1989, has now been approved by the US Food and Drug Administration (FDA) for treatment of depression. It is being advertised as having a 'favorable side-effect profile.'

The FDA recently approved the proton pump inhibitor omeprazole magnesium (Prilosec OTC) for over-the-counter use for treatment of frequent heartburn. It will be marketed in late September or early October. Five proton pump inhibitors, including omeprazole, are available by prescription in the US (Medical Letter 2001; 43:36).

Terfenadine (Seldane - Marion Merrell Dow) and astemizole (Hismanal - Janssen) are nonsedating antihistamines widely used to treat symptoms of allergic rhinitis (Medical Letter, 27:65, 1985; 31:43, 1989). Both are available without a prescription in Canada, and the US Food and Drug Administration is apparently considering terfenadine for over-the-counter availability in the USA.

Metformin (Glucophage - Bristol-Myers Squibb), a hypoglycemic agent, was recently marketed in the USA for oral treatment of patients with non-insulin-dependent diabetes mellitus (NIDDM) not adequately controlled by diet alone. Previously marketed in more than ninety countries, including Canada, metformin (dimethylbiguanide) is chemically related to phenformin (phenylethylbiguanide), which was withdrawn from the US market in 1976 because it caused a high incidence of lactic acidosis. In approving metformin, the US Food and Drug Administration stipulated that a post-marketing controlled...

Zolmitriptan (Zomig - Zeneca), a selective serotonin (5-HT1)-receptor agonist, is now available in the USA for oral treatment of migraine headache. Zomitriptan structurally resembles sumatriptan (Imitrex - Medical Letter 34:91, 1992). Drugs currently used for acute treatment of migraine include injectable, oral and nasal spray formulations of sumaptriptan, injectable dihydroergotamine, dihydroergotamine nasal spray, ergotamine tartrate alone or with caffeine, and various analgesics. Anoterh 5-HT1-receptor agonist, naratriptan (Amerge - Gaxo Wellcome), has been approved by the FDA but has not...