The FDA has approved vigabatrin (vye gá ba trin; Sabril – Lundbeck) for oral use as add-on therapy for complex partial seizures in adults who are refractory to several antiepileptic drugs and as monotherapy for infantile spasms. Vigabatrin has been available in other countries for many years. Because of its potential for retinal toxicity, it will be available in the US only through a restricted distribution program called SHARE (Support, Help and Resources for Epilepsy). Prescribers and pharmacists distributing the drug must register, and patients must undergo visual field testing.

The FDA has approved lemborexant (Dayvigo – Eisai), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. It is the second orexin receptor antagonist to be approved for this indication; suvorexant (Belsomra) was the first.

Astemizole (Hismanal - Janssen), a new antihistamine, was recently marketed in the USA for treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. Like terfenadine (Seldane - Medical Letter, 27:65, 1985), astemizole is claimed to be no more sedating than placebo, but the new drug offers the advantage of a once-daily dosage schedule.

Desogen (Organon) and Ortho-Cept (Ortho), two oral contraceptives each containing a low dose (30 mcg) of the estrogen ethinyl estradiol plus 150 mcg of the progestin desogestrel, were recently approved by the US Food and Drug Administration for marketing in the USA. They are the first US oral contraceptives to contain desogestrel, which is widely used in oral contraceptive combination products in other countries. Desogestrel is one of three new progestins (norgestimate and gestodene are the others) considered less androgenic than previously available progestins (L Speroff et al, Obstet...

Ardeparin sodium (Normiflo - Wyeth-Ayerst), a low-molecular-weight heparin, and danaparoid sodium (Orgaran - Organon), a heparinoid, have been approved by the FDA for prevention of deep vein thrombosis. Without anticoagulation, deep vein thrombosis occurs in up to 30% of patients after abdominal surgery, and in 40% to 70% of patients after major orthopedic operations on the lower limbs. Danaparoid sodium is approved in the USA only for use in hip replacement. Ardeparin is approved here only for use in knee replacement.

The US Food and Drug Administration (FDA) has approved two new retinoids for treatment of psoriasis. Tazarotene gel 0.05% and 0.1% (Tazorac - Allergan) is being marketed for topical use in patients with stable, mild to moderate plaque psoriasis. Acitretin (Soriatane - Roche) is being promoted for systemic use in severe psoriasis.

Trovafloxacin (Trovan - Pfizer) and its prodrug alatrofoxacin (Trovan IV) are new fluroroquinolones marketed for an unusually wide variety of infections, including oral and intravenous treatment of nosocomial and community-acquired pneumonia, acute ecerbations of chronic bronchitis, acute sinusitis, complicate intra-abdominal and pelvic infections, diabetic foot infection, uncomplicated urinary tract infection, prostatitis, cervicitis and uncomplicated gonorrhea.

Aggrenox, a fixed-dose oral combination of aspirin and extended-release dipyridamole, is now being advertised for secondary prevention of a transient ischemic attack (TIA) or ischemic stroke.

Epirubicin, an analog of doxorubicin that has been available in Europe and Canada for 15 years, has now been approved by the FDA for adjuvant use after resection of the primary tumor in breast cancer patients with axillary node involvement.

Even though its effectiveness has not been established, many patients take St. John's Wort (Hypericum perforatum), an over-the-counter herbal extract, to treat symptoms of depression, often without the knowledge of their physicians. Recent reports indicate that St. John's wort interacts adversely with a number of drugs.