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...

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.

The FDA has approved the oral GABA_A receptor modulator zuranolone (Zurzuvae – Sage Therapeutics/Biogen) for treatment of postpartum depression (PPD). Zuranolone is the second drug to be approved for this indication; brexanolone (Zulresso), another GABA_A receptor modulator, was approved for IV treatment of PPD in 2019.

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.

View the Table: Over the Counter At-Home Tests for COVID-19

The FDA has approved a 0.75% ophthalmic solution of the alpha-adrenergic antagonist phentolamine (Ryzumvi – Viatris) for treatment of mydriasis produced by adrenergic agonists such as phenylephrine or parasympatholytic agents such as tropicamide in patients ≥3 years old. Ryzumvi is the first drug to be approved in the US for reversal of pharmacologically induced mydriasis.

Mefloquine hydrochloride (Lariam - Roche), a new antimalarial drug chemically related to quinine, has been approved by the US Food and Drug Administration (FDA) for prevention and treatment of Plasmodium falciparum and P. vivax malaria.

The FDA has approved eliglustat (Cerdelga – Genzyme), an oral glucosylceramide synthase inhibitor, for treatment of adults with type 1 Gaucher disease. Eliglustat is metabolized primarily by CYP2D6. Because patients who are CYP2D6 ultra-rapid metabolizers may not achieve therapeutic concentrations and a specific dosage cannot be recommended for indeterminate metabolizers, the FDA has approved the drug only for patients who are extensive, intermediate, or poor metabolizers of CYP2D6.

Permethrin 5% (Elimite Cream - Herbert), a synthetic pyrethroid previously available in a 1% concentration (Nix) for treatment of head lice (Medical Letter, 28:89, 1986) and as an aerosol clothing spray (Permanone) for protection against mosquitoes and ticks (Medical Letter, 31:45, 1989), was recently approved by the US Food and Drug Administration for single-application treatment of infestation with Sarcoptes scabiei (scabies).

Temozolomide has received accelerated approval from the FDA for oral treatment of adults with anaplastic astrocytoma that has relapsed after treatment with a nitrosourea (lomustine or carmustine) and procarbazine.