Bexagliflozin (Brenzavvy – TheracosBio), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved by the FDA to improve glycemic control in adults with type 2 diabetes. It is the fifth SGLT2 inhibitor to be approved in the US for this indication (see Table 4).

The FDA has approved tirzepatide (Mounjaro – Lilly), a peptide hormone with activity at both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, to improve glycemic control in adults with type 2 diabetes. Tirzepatide, which is injected subcutaneously once weekly, is the first dual GIP/GLP-1 receptor agonist to become available in the US. Selective GIP receptor agonists are not available in the US; GLP-1 receptor agonists have been available for years.

The FDA has approved Airsupra (AstraZeneca), a metered-dose inhaler containing the short-acting beta₂-agonist (SABA) albuterol and the inhaled corticosteroid (ICS) budesonide, for use as needed for treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients ≥18 years old with asthma. Airsupra is the first combination of a SABA and an ICS to become available in the US. It is not approved for use as maintenance therapy.

The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for treatment of eosinophilic esophagitis (EoE) in patients ≥12 years old who weigh ≥40 kg and treatment of prurigo nodularis in adults. Dupilumab is the first drug to be approved in the US for each of these indications. It is also FDA-approved for treatment of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.

The FDA has approved fenfluramine oral solution (Fintepla – Zogenix) for treatment of seizures in patients ≥2 years old with Dravet syndrome. It is the third drug to be approved for this indication. Stiripentol (Diacomit) and cannabidiol (Epidiolex), a purified product derived from marijuana, were approved earlier.

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide, previously approved by the FDA as Ozempic to treat type 2 diabetes and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, has now been approved in a higher dose as Wegovy (Novo Nordisk) for chronic weight management in adults with or without type 2 diabetes who have a body mass index (BMI) ≥30 kg/m2 or a BMI ≥27 kg/m2 and ≥1 weight-related comorbidity (e.g., hypertension, dyslipidemia). An oral formulation of semaglutide...

The FDA has approved Symbravo (Axsome), an oral fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam and the 5-HT_1B/1D receptor agonist (triptan) rizatriptan (Maxalt, and generics), for acute treatment of migraine with or without aura in adults. It is the second combination of an NSAID and a triptan to be approved for migraine treatment. An oral fixed-dose combination of sumatriptan and naproxen (Treximet, and generics) is approved for use in patients ≥12 years old.

The FDA has approved IV amisulpride (Barhemsys – Acacia), a selective dopamine-2 and -3 (D₂/D₃) receptor antagonist, for prevention and treatment of postoperative nausea and vomiting (PONV) in adults. It is the first antiemetic to be approved for rescue treatment of PONV in patients who have symptoms despite receiving antiemetic prophylaxis. Oral formulations of amisulpride are available in Europe for treatment of schizophrenia and acute psychotic episodes.

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 Suflave (Sebela/Braintree), a low-volume polyethylene glycol (PEG)- and sulfate-based product for cleansing of the colon prior to colonoscopy in adults. Other oral colonoscopy preparations available in the US are listed in Table 2. Suflave is marketed as tasting better than other products.