Pravastatin - Bristol-Myers Squibb) and simvastatin (Zocor -Merck), two new inhibitors of cholesterol synthesis similar to lovastatin (Mevacor - Merck), have now been marketed in the USA for treatment of hypercholesterolemia. Lovastatin (Medical Letter, 29:99, 1987) is the most frequently prescribed of all cholesterol-lowering drugs in the USA. Pravastatin and simvastatin were previously reviewed in The Medical Letter when they became available in Canada (volume 33, page 18, 1991).

Mycophenolate mofetil (CellCept - Roche) has been approved by the US Food and Drug Administration for oral use in preventing organ rejection in patients receiving allogeneic renal transplants. It is being promoted as an improvement over azathioprine (Imuran) for concurrent use with cyclosporine (Sandimmune; Neoral) and corticosteroids.

Valacyclovir (Valtrex - Glaxo Wellcome), an L- valyl ester of acyclovir (Zovirax), has been approved by the US Food and Drug Administration (FDA) for oral treatment of herpes zoster (shingles) in immunocompetent adults. Famciclovir (Famvir - Medical Letter, 36:97, 1994) is also available for this indication.

The US Food and Drug Administration (FDA) recently approved the marketing of clarithromycin (Biaxin - Abbott), a macrolide antibiotic, and omeprazole (Prilosec - Astra Merck), a proton pump inhibitor, for concurrent use in treatment of duodenal ulcers associated with Helicobacter pylori.

Imiquimod (i mi kwi' mod) 5% cream (Aldara - 3M Pharmaceuticals) has been approved by the FDA for treatment of external genital and perianal warts (condyloma acuminata). The drug requires a prescription but is applied by the patient. It is the second patient-applied treatment to become available for external genital warts; the first was podofilox (Condylox - Medical Letter, 33:117, 1991).

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.

Recombinant human α-L-iduronidase (laronidase; Aldurazyme BioMarin/Genzyme), an orphan drug, has been approved by the FDA for enzyme replacement therapy in mucopolysaccharidosis (MPS) type I, a lysosomal storage disorder caused by deficiency of the enzyme. This review describes the disease, treatment, adverse effects and cost.

Soon after The Medical Letter first reviewed use of natalizumab (Tysabri – Biogen Idec and Elan) for treatment of relapsing forms of multiple sclerosis (MS) (Med Lett Drugs Ther 2005; 47:13), the drug was withdrawn from the market. The unpublished clinical trials that led to its approval by the FDA have since been published, and now the drug has been returned to the market with prescribing restrictions.Natalizumab decreases the number of relapses and new brain lesions in patients with MS. It was withdrawn because progressive multifocal leukoencephalopathy (PML) occurred in 3 (of about 3000)...

The FDA has licensed a 13-valent conjugate pneumococcal vaccine (PCV13; Prevnar 13 – Pfizer) for the prevention of invasive pneumococcal disease (IPD) in infants and children <6 years old. It replaces Prevnar (PCV7). An unconjugated 23-valent polysaccharide vaccine (PPSV23; Pneumovax 23 – Merck) is FDA-approved for use in adults.