The FDA has approved a 12.5-mg tablet formulation of the thiazide-like diuretic chlorthalidone (HemiClor – Ingenus) for treatment of hypertension. Chlorthalidone has been available for years in 15-, 25-, and 50-mg tablets (Thalitone, and generics) and in fixed-dose combinations with azilsartan medoxomil (Edarbyclor) and atenolol (Tenoretic, and generics).

Eylea HD (Regeneron), which contains 8 mg of the vascular endothelial growth factor (VEGF) inhibitor aflibercept, has now been approved by the FDA for intravitreal treatment of macular edema following retinal vein occlusion (RVO). A 2-mg dose of aflibercept (Eylea) was approved previously for this indication. Eylea and Eylea HD are also approved for treatment of neovascular (wet) age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.

The FDA has approved the over-the-counter (OTC) sale of Rextovy (Amphastar), a nasal spray formulation of the opioid antagonist naloxone, for emergency treatment of opioid overdose. Other naloxone nasal sprays (Narcan, and generics; RiVive) are also available OTC (see Table 1).

The FDA has approved Clenpiq (Ferring), a low-volume oral solution that contains sodium picosulfate, magnesium oxide, and anhydrous citric acid, for colon cleansing prior to colonoscopy in adults. The ready-to-drink solution contains the same ingredients as Prepopik, which is supplied as a powder for reconstitution.

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...

Adults with persistent fasting triglyceride levels ≥150 mg/dL are considered to have hypertriglyceridemia; when levels are ≥500 mg/dL, it is considered severe. Hypertriglyceridemia is associated with an increased risk of atherosclerotic cardiovascular disease (ASCVD); severe hypertriglyceridemia increases the risk of acute pancreatitis.