Finasteride (Proscar - Merck) has now been approved by the US Food and Drug Administration (FDA) for oral treatment of benign prostatic hyperplasia. A 4-aza-steroid, the drug is a specific inhibitor of steroid 5 -reductase, the enzyme that catalyzes conversion of testosterone to dihydrotestosterone. Dihydrotestosterone is required for development and maintenance of prostatic hypertrophy (JS Tenover, Endocrinol Metab Clin North Am, 20:893, 1991).

Loratadine (Claritin - Schering), a new H 1 -receptor antagonist, has been approved by the U.S. Food and Drug Administration for treatment of seasonal allergic rhinitis in patients more than 12 years old. It will compete with older, relatively sedating drugs such as chlorpheniramine (Chlor-Trimeton, and others) and clemastine (Tavist - Medical Letter, 35:9, 1993) and with newer relatively non-sedating agents such as terfenadine (Seldane) and astemizole (Hismanal).

An intrathecal formulation of the muscle relaxant baclofen (Lioresal Intrathecal - Medtronic) has been approved by the US Food and Drug Administration for treatment of spasticity due to multiple sclerosis (MS) or spinal cord injury. Its use requires subcutaneous implantation of a drug pump, which infuses the drug into the subarachnoid space. Baclofen (Lioresal [Ciba-Geigy], and others) has been available as an oral formulation for many years (Medical Letter 20:43, 1978), but its use has been limited by central-nervous-system effects such as drowsiness and confusion.

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.

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.

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.

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.

Cefepime hydrochloride (Maxipime - Bristol-Myers Squibb), a new 'fourth-generation' cephalosporin, has been approved by the US Food and Drug Administration (FDA) for parenteral treatment of urinary tract infections and skin and skin-structure infections due to susceptible pathogens, and for moderate to severe pneunmonia caused by Streptococcus pneumoniae (pneumococci), Pseudomonas aeruginosa, Enterobacter or Klebsiella pneumoniae.

Docetaxel (Taxotere - Rh ne-Poulenc Rorer), a semisynthetic taxoid similar to paclitaxel (Taxol - Medical Letter, 35:39, 1993), has been approved by the US Food and Drug Administration for use in locally advanced or metastatic breast cancer that has progressed or relapsed during treatment that included an anthracycline such as doxorubicin (Adriamycin, and others).