Fensolvi (Tolmar), a long-acting subcutaneous formulation of the gonadotropin-releasing hormone (GnRH) agonist leuprolide acetate, has been approved by the FDA for treatment of central precocious puberty (CPP) in children ≥2 years old. It is the first formulation of the drug to be approved for SC administration once every 6 months. IM formulations of leuprolide acetate, which are given once monthly or every 3 months, and the GnRH agonists histrelin acetate (Supprelin LA) and triptorelin (Triptodur) have been available for years for treatment of CPP.

The FDA has approved cantharidin 0.7% solution (Ycanth – Verrica) for topical treatment of molluscum contagiosum in patients ≥2 years old. Ycanth was the first drug to be approved in the US for this indication. A 10.3% gel formulation of berdazimer (Zelsuvmi), a nitric oxide-releasing agent, has also been approved by the FDA for treatment of molluscum contagiosum (in patients ≥1 year old); it will be reviewed in a future issue.

Attention-deficit/hyperactivity disorder (ADHD) is a chronic neurodevelopmental disorder that has been diagnosed in up to 10% of school-age children in the US and frequently persists into adulthood. A study in a large Danish cohort found that ADHD was associated with higher mortality rates in children, adolescents, and adults, mainly due to accidents. Pharmacologic treatment of ADHD in children has been reported to decrease the risk of substance abuse in adolescents, and use of ADHD medications in adults has been associated with a reduced risk of serious traffic accidents and...

Recombinant interferon alfa-2b (Intron A - Schering) was recently approved by the US Food and Drug Administration (FDA) for intralesional treatment of genital warts (condylomata acuminata). Interferon was previously available only for treatment of hairy-cell leukemia (Medical Letter, 28:78, 1986).

Pravastatin (Pravachol - Bristol-Myers Squibb) and simvastatin (Zocor - Merck), two new inhibitors of cholesterol synthesis similar to lovastatin (Mevacor - Merck), have been marketed in Canada and several European countries and may soon be available in the USA for treatment of high plasma cholesterol concentrations. Drugs already marketed here for this indication were recently reviewed in The Medical Letter (Volume 33, page 1, January 11, 1991).

Diagnostic tests for human immunodeficiency virus (HIV) infection use four approaches: identification of antibodies to viral proteins, detection of viral antigens, detection of viral nucleic acids, and culturing the virus (CJ Schleupner in GL Mandell et al, eds, Principles and Practice of Infectious Diseases, 4th ed, New York:Churchill Livingstone, 1995, page 1253). In recent years, the FDA has approved the use of a 10- minute blood test, two home collection kits, and office tests that use urine and oral secretions to diagnose HIV infection. One home test, Confide (Johnson & Johnson), was...

Amprenavir is the fifth protease inhibitor to become available for treatment of HIV infection. It was approved by the FDA for use with other drugs in the treatment of HIV-infected adults and children at least four years old.

The FDA has approved use of gamma hydroxybutyrate (sodium oxybate is the official generic name; Xyrem - Orphan Medical) for oral treatment of cataplexy in patients with narcolepsy. Gamma hydroxybutyrate (GHB), a metabolite of gamma-aminobutyric acid (GABA), is a central-nervous-system depressant marketed in Europe for use in general anesthesia. In recent years it has been notorious for its use in "date-rape" (Medical Letter 2002; 44:21). Xyrem is a Schedule III controlled substance.

Eletriptan hydrobromide (Relpax Pfizer) is now available in the US for oral treatment of migraine headache in adults. It is the seventh serotonin 5-HT1B/1D-receptor agonist (triptan) to be approved by the FDA for this indication. This review describes the pharmacokinetics, adverse effects, drug interactions and recommended dosage of eletriptan. Clinical trials comparing the new drug to placebo and to sumatriptan are presented. A dosage and cost table for all the triptans available in the US is also included. The review concludes with an overall assessment of eletriptan's efficacy and...

Abarelix (Plenaxis - Praecis Pharmaceuticals), an injectable gonadotropin-releasing hormone (GnRH) antagonist, has been approved by the FDA for treatment of advanced symptomatic prostate cancer in patients who should not take luteinizing hormone-releasing hormone (LHRH) agonists and who refuse treatment with surgical castration.