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?

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).

Eplerenone (e pler' en one; Inspra - Pharmacia), an aldosterone receptor antagonist similar to spironolactone (Aldactone, and others), has been approved by the FDA, but not yet marketed, for treatment of hypertension. It has also been tried for treatment of heart failure.

The FDA has approved an extended-release (XR) formulation of the benzodiazepine alprazolam (Xanax XR - Pfizer) for treatment of panic disorder, with or without agoraphobia. The new formulation is intended to reduce the need for frequent dosing and problems of interdose anxiety. This review describes the effectiveness of the extended-release formulation, as well as sections on dependence, abuse and withdrawal, adverse effects, and drug interactions. The review concludes with an overall assessment of the drug's efficacy and cost.

Enfuvirtide (T-20; Fuzeon Trimeris/Roche), the first in a new class of HIV drugs known as fusion inhibitors, has received accelerated approval from the FDA for use with other antiretrovirals in adults and children with viral replication despite ongoing antiretroviral therapy. This review describes the mechanism of action and pharmacokinetics of the new drug, and outlines the results of the 2 clinical studies that led to its approval. Sections on adverse effects, development of resistance, and dosage and cost are also included. The review concludes with an overall assessment of the...

Agalsidase beta (Fabrazyme Genzyme) has received accelerated approval from the FDA for treatment of patients with Fabry disease, an inherited lysosomal storage disease caused by deficiency of α-galactosidase A. Agalsidase beta is a recombinant form of human α-galactosidase A. This review provides an overview of this rare disease, including its clinical manifestations. The clinical trials conducted with the new drug are also described, as well as its adverse effects, dosage, and cost. Appropriate indications for use of Fabrazyme are summarized.

The FDA has approved Humatrope, Lilly's brand of recombinant human growth hormone (somatropin), for long-term treatment of children with idiopathic, non-growth-hormone-deficient (NGHD) short stature who are more than 2.25 standard deviations below the mean height for their age and sex. This review describes the clinical studies, adverse effects, and includes a cost table for other brands of somatropin.

Many women of child-bearing age now take folic acid supplements of 400 ╡g per day to prevent neural tube defects in their offspring (Medical Letter 1998; 40:75). An FDA advisory committee has recommended development of a combination tablet containing an oral contraceptive and 400 ╡g of folic acid. A recent editorial in the New England Journal of Medicine suggested that folic acid doses should be higher (NJ Wald, N Engl J Med 2004; 350:101).