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.

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).

Solar ultraviolet (UV) light capable of injuring the skin is classified by wavelength into UVA I (340-400 nm), UVA II (320-340 nm) and UVB (290-320 nm). UVB is responsible for most of the erythema of sunburn. UVA has been implicated in the development of phototoxicity and photoaging. The FDA permits sunscreen manufacturers to claim broad-spectrum protection if their products block at least part of UVA II in addition to UVB.

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The ViewPoint CK System (Refractec) for conductive keratoplasty (CK), previously approved by the FDA as a device for treatment of hyperopia (farsightedness), was recently approved for treatment of presbyopia (age-associated loss of ability to view near objects).

Methamphetamine, a highly addictive synthetic sympathomimetic, has again become important as a drug of abuse in the US. Its resurgence has been associated with unsafe sexual practices that have resulted in an increase in HIV transmission, particularly among men who have sex with men (SJ Semple et al, J Subst Abuse Treat 2002; 22:149; A Urbina and K Jones, Clin Infect Dis 2004; 38:890).

Trospium chloride (Sanctura - Indevus/Odyssey) has been approved by the FDA for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. It has been available in Europe for many years.