Colesevelam hydrochloride (Welchol - Sankyo Pharma), a nonabsorbed hydrophilic polymer that binds bile acids, has been approved by the FDA for reduction of plasma LDL cholesterol in patients with primary hypercholesterolemia.

Many drugs, mostly azole derivatives, are marketed in the USA for topical treatment of vulvovaginal candidiasis. A single-dose, sustained-release formulation of butoconazole nitrate 2% cream (Gynazole 1) is the newest addition. Fluconazole (Diflucan) is approved for single-dose oral treatment.

Palivizumab (Synagis - MedImmune), an injectable monoclonal antibody, has been marketed in the USA since 1999 for prevention of respiratory syncytial virus (RSV) disease in high-risk infants and children.

Formoterol fumarate inhalation powder Foradil Aerolizer, a long-acting beta2-adrenergic receptor agonist, has been approved by the FDA for maintenance treatment of asthma and prevention of exercise-induced bronchospasm. The drug has been available in Europe for many years.

Balsalazide disodium (Colazal), a prodrug of mesalamine, was marketed in the US this year for oral treatment of mildly to moderately active ulcerative colitis. Oral formulations of mesalamine have been available in the US for nine years for treatment and maintenance of remissions and olsalazine, which is a dimer of mesalamine, is marketed for maintenance of remissions but not for treatment. Balsalazide has been available in Europe for four years.

Insulin aspart (Novolog - Novo Nordisk) is the second rapid-acting insulin analog to be approved by the FDA. The first was insulin lispro (Humalog). Insulin aspart differs from human insulin by substitution of aspartic acid for proline in position 28 on the beta-chain.

Cefditoren pivoxil (Spectracef — TAP), a new oral third-generation cephalosporin, has been approved by the FDA for treatment of acute exacerbations of chronic bronchitis, pharyngitis, tonsillitis and uncomplicated skin and soft tissue infections in adults and children 12 or more years old. The drug has been used in Japan for 7 years.

Two controlled-release formulations of triptorelin (trip toe rel' in) pamoate, an agonist analog of human luteinizing hormone-releasing hormone (LHRH), are now available in the US for parenteral treatment of advanced prostate cancer. Trelstar Depot is given every 4 weeks and Trelstar LA every 12 weeks. Triptorelin has been available in some countries since 1986.

Tazarotene (taz ar' oh teen, Tazorac - Allergan), an acetylinic retinoid marketed for treatment of psoriasis (Medical Letter 1997; 39:105), is also available as a 0.1% gel and cream for treatment of acne.

Patients with lung cancer may be asking their physicians about gefitinib (ge fi' tye nib; ZD1839; Iressa -- AstraZeneca), because it has been the subject of positive coverage in the media. An inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase, this oral drug has not been approved by the FDA, but is in clinical trials in the US for treatment of non-small cell lung cancer (NSCLC) and some other solid tumors. Iressa was recently approved in Japan, and is available from the manufacturer on a "compassionate-use" basis in the US (800-236-9933).