Samarium-153 lexidronam (Quadramet - Dupont Pharma) has been approved by the FDA for relief of pain in patients with osteoblastic bone metastases. Strontium-89 (Metastron) has been available for several years for this indication (Medical Letter, 35:102, 1993).

RabAvert (Chiron), a new human rabies vaccine prepared in purified chick embryo cell culture (PCEC), has been marketed in the USA for pre- and post-exposure prophylaxis. It is available in other countries as Rabipur. Human rabies is rare in the United States, but thousands of people receive post-exposure prophylaxis every year (DL Noah et al, Ann Intern Med, 128:922, June 1, 1998).

Rifapentine, a long-acting analog of rifampin developed in the 1960's, has received an accelerated approval from the FDA for oral use, with at least one other drug, in the treatment of pulmonary tuberculosis.

The FDA has approved a new formulation of fluoxetine for once-weekly maintenance treatment of depression in patients who have responded to daily fluoxetine (Prozac).

Isotretinoin (Accutane - Roche), an effective oral drug for treatment of acne, will soon be available generically. Concerns about its adverse effects, particularly psychiatric symptoms in adolescents, have been widely reported in the media.

A nasal spray formulation of cyanocobalamin (Nascobal – Questcor) has been approved by the FDA for maintenance treatment of vitamin B12 deficiency. Nascobal is already available as an intranasal gel. Vitamin B12 deficiency, diagnosed by elevated serum concentrations of methylmalonic acid with or without elevated serum homocysteine and low serum B12 concentrations (<200 pg/mL), is common in older patients.1Since intestinal absorption of B12 may be impaired, the usual maintenance treatment of deficiency is intramuscular injection of the vitamin in doses of 1 mg every 4 weeks (after more...

An unpublished 2-year randomized study (ENHANCE) on the effect of adding ezetimibe 10 mg to simvastatin 80 mg in 720 patients with heterozygous familial hypercholesterolemia has been in the news recently. About 80% of these patients had previously been treated with statins. The primary endpoint was the change in the intima-media thickness (IMT) of the carotid artery (baseline 0.68 and 0.69 mm); the IMT increased by 0.0111 mm with ezetimibe plus simvastatin and 0.0058 mm with simvastatin 80 mg alone (p=0.29). The ezetimibe- simvastatin combination lowered LDL-C by 58% compared to 41% lowering...

The FDA has approved use of denosumab (Prolia – Amgen) for treatment of osteoporosis in postmenopausal women at high risk for fracture.

The FDA has approved ivacaftor (eye va kaf’ tor; Kalydeco – Vertex) for oral treatment of cystic fibrosis (CF) in patients ≥6 years old with the G551D mutation, which is found in about 5% of patients with CF. It is the first drug approved in the US that treats the cause of the disease.

The FDA has approved enzalutamide (en za loo’ ta mide; Xtandi – Astellas/Medivation) for oral treatment of metastatic castration-resistant prostate cancer in patients previously treated with docetaxel (Taxotere, and generics). It is the second oral drug approved for this indication; abiraterone acetate (Zytiga), which is also approved for first-line use, was the first. Cabazitaxel (Jevtana), which is given parenterally, has a similar indication.