The FDA has approved the proton-pump inhibitor (PPI) dexlansoprazole (Kapidex - Takeda), a delayed release formulation of the R-enantiomer of lansoprazole (Prevacid - Takeda), for treating and maintaining healing of erosive esophagitis and for treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD).

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).

When patents expire on brand-name drugs and generic formulations become available, patients and managed care organizations may express a preference for the lower-cost generics. Are they equivalent to the brand-name product?

Valacyclovir (Valtrex - GlaxoSmithKline) was recently approved by the FDA for one-day oral treatment of patients at least 12 years old with orolabial herpes simplex infections. The drug was previously approved for treatment and suppression of genital herpes and for treatment of herpes zoster (shingles).

Dutasteride (Avodart - GlaxoSmithKline) is now available in the US for oral treatment of benign prostatic hyperplasia (BPH). It is similar to finasteride (Proscar - Merck), which has been marketed for this indication since 1992 and also, since 1998, for alopecia (Propecia - Medical Letter 1998; 40:25).

The heptavalent pneumococcal conjugate vaccine (Prevnar - Wyeth) previously approved by the FDA for prevention of invasive pneumococcal disease in infants and children (Medical Letter 2000; 42:25) has now also been approved for prevention of otitis media. Infants and young children have higher antibody responses to the heptavalent conjugate vaccine (PCV7) than to the older 23-valent pneumococcal polysaccharide vaccine (PPV23) used in adults and older children (D Murray and C Jackson, Mil Med 2002; 167:671).