Bepridil hydrochloride (Vascor - McNeil Pharmaceutical/Wallace Laboratories), a calcium-channel blocking agent chemically unrelated to verapamil (Calan, and others), nifedipine (Procardia, and others), or other drugs in this class, was recently approved by the US Food and Drug Administration for oral treatment of chronic stable angina pectoris. Because of its potential adverse effects, the labeling recommends reserving the drug for patients who fail to respond optimally to or are intolerant of other antianginal agents.

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.

Zileuton (zye loo' ton; Zyflo - Abbott), an inhibitor of leukotriene synthesis, has been approved by the US Food and Drug Administration (FDA) for prophylaxis and maintenance treatment of chronic asthma in adults and children more than 12 years old. A related drug—zafirlukast (Accolate), a leukotriene receptor antagonist—was recently reviewed in the Medical Letter (vol. 38, page 111, December 20, 1996). Neither of these drugs is recommended for treatment of acute asthma.

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).

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.

Rivastigmine tartrate (Exelon - Novartis), a carbamate-based cholinesterase inhibitor, is now being marketed for treatment of patients with dementia due to Alzheimer's disease.

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.

Tinzaparin sodium, a low molecular weight heparin, has been approved by the FDA for treatment of acute deep vein thrombosis.

Galantamine hydrobromide (Reminyl), a tertiary alkaloid and phenanthrene derivative extracted from daffodil bulbs, is now being marketed for oral treatment of mild to moderate Alzheimer's disease. Galantamine is the fourth acetylcholinesterase inhibitor approved for this indication.

Botulinum toxin type A (Botox - Allergan) has been approved by the FDA for treatment of severe underarm sweating ("primary axillary hyperhidrosis"). Injected into the skin, botulinum toxin decreases sweating by causing chemical denervation of the sweat gland.