The oral antimalarial tafenoquine succinate, a long-acting analog of primaquine, has been approved by the FDA in 2 different strengths. Arakoda (100-mg tablets; Sixty Degrees) is indicated for the prophylaxis of malaria in adults. Krintafel (150-mg tablets; GSK) is indicated for the prevention of relapse (radical cure) of Plasmodium vivax malaria in patients ≥16 years old undergoing treatment for acute P. vivax infection.

Lefamulin (Xenleta – Nabriva), a semisynthetic pleuromutilin antibiotic, has been approved by the FDA for IV and oral treatment of community-acquired bacterial pneumonia (CABP) in adults. It is the first systemic pleuromutilin antibiotic to be approved in the US; retapamulin (Altabax), a 1% topical ointment for treatment of impetigo, was approved in 2007.

The FDA has approved an oral tablet formulation of sodium sulfate, magnesium sulfate, and potassium chloride (Sutab – Braintree) for colon cleansing prior to colonoscopy in adults. A sodium sulfate-based oral solution (Suprep) has been available in the US since 2010. Sutab is the second tablet formulation to be approved for bowel cleansing prior to colonoscopy; a sodium phosphate-based tablet (OsmoPrep) was approved earlier.

The FDA has approved nirsevimab-alip (Beyfortus – AstraZeneca/Sanofi), a long-acting monoclonal antibody, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children ≤24 months old who are at increased risk for severe RSV disease through their second RSV season. Nirsevimab is the first drug to be approved for protection of all infants during their first RSV season.

The FDA has approved lebrikizumab-lbkz (Ebglyss – Lilly), a subcutaneously injected interleukin (IL)-13 antagonist, for treatment of moderate to severe atopic dermatitis that has not been or cannot be adequately treated with topical therapy in patients ≥12 years old (weight ≥40 kg). Lebrikizumab is the third subcutaneously injected human IgG4 monoclonal antibody to be approved in the US for this indication. Tralokinumab (Adbry), another IL-13 antagonist, is also approved for use in patients ≥12 years old, and dupilumab (Dupixent), an IL-4 and IL-13 inhibitor, is approved for...

Acesulfame potassium (Sunette - Hoechst), an oxathiazinondioxide, was recently approved by the US Food and Drug Administration (FDA) for use as a non-caloric table-top sweetener and as an ingredient in chewing gum, powdered beverages, gelatins and puddings. The other non-caloric artificial sweeteners available in the USA are saccharin (Sweet 'N Low; and others) and aspartame (NutraSweet; Equal) (Medical Letter, 24:1, 1982).

The 1990 labeling for Norpramin, the Merrell Dow brand of the tricyclic antidepressant desipramine, reports the occurrence of sudden death in an eight-year-old child treated with the drug. Desipramine is also available as Pertofrane (Rorer) and generically.

Two new substitutes for fat will soon be available in supermarkets in the USA, not directly, but incorporated into low-fat foods. Simplesse (NutraSweet) has already been approved for use by the US Food and Drug Administration (FDA) and is commercially available in some areas, but only in an ice-cream-like product called Simple Pleasures. Trailblazer (Kraft General Foods) is expected to be approved soon.

Gamma hydroxy butyrate (GHB) sold in health food stores has recently caused outbreaks of gastrointestinal illness, central-nervous-system (CNS) depression, and seizures.

Breathe Right, an adhesive bandage device that pulls open the nostrils, has been approved by the US Food and Drug Administration and is being heavily promoted to the general public as a treatment for snoring and night-time nasal congestion. The manufacturer's suggested retail price is $4.99 for a box of 10 strips.