The FDA has approved a 1.5% topical foam formulation of minocycline (Zilxi – Foamix) for treatment of inflammatory lesions of rosacea in adults. It is the only topical minocycline product approved for this indication. The same manufacturer markets minocycline foam 4% (Amzeeq) for treatment of acne in patients ≥9 years old.

The FDA has approved Gimoti (Evoke), a nasal spray formulation of the dopamine-2 (D₂) receptor antagonist metoclopramide, for relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Metoclopramide (Reglan, and generics) has been available for years in conventional and orally-disintegrating tablets and in an injectable formulation. It is the only drug that is FDA-approved for treatment of diabetic gastroparesis.

The FDA has approved remimazolam (Byfavo – Acacia Pharma), an ultra-short-acting IV benzodiazepine, for induction and maintenance of sedation in adults undergoing procedures of up to 30 minutes' duration.

The FDA has approved Relyvrio (Amylyx), a fixed-dose combination of sodium phenylbutyrate and taurursodiol, for treatment of amyotrophic lateral sclerosis (ALS). Sodium phenylbutyrate (Buphenyl, and others) has been available by prescription for years for treatment of urea cycle disorders. Taurursodiol (tauroursodeoxycholic acid), a derivative of ursodiol, is an over-the-counter bile acid supplement claimed to have neuroprotective benefits. Relyvrio is the third drug to be approved in the US for treatment of ALS; riluzole (Rilutek, and others) and edaravone (Radicava, Radicava...

The FDA has approved a dextroamphetamine transdermal patch (Xelstrym – Noven) for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old. Xelstrym is the first transdermal amphetamine product to be approved in the US. A methylphenidate transdermal patch (Daytrana, and generics) has been available for years for treatment of ADHD.

The FDA has approved ritlecitinib (Litfulo – Pfizer), an oral JAK and TEC kinase family inhibitor, for treatment of severe alopecia areata in patients ≥12 years old. Ritlecitinib is the second oral drug to be approved in the US for treatment of severe alopecia areata; baricitinib (Olumiant), a JAK inhibitor, is approved only for use in adults.

Donanemab-azbt (Kisunla – Lilly), an IV amyloid beta-directed monoclonal antibody, has been approved by the FDA for treatment of Alzheimer's disease (AD). The label states that the drug should only be started in patients with mild cognitive impairment (MCI) or mild dementia. Donanemab is the third IV amyloid beta-directed monoclonal antibody to be marketed in the US. Lecanemab (Leqembi – Biogen/Eisai) was approved by the FDA in 2023 for the same indication as donanemab. Aducanumab (Aduhelm – Lilly) was granted accelerated approval in 2021, but it was withdrawn from the market...

The FDA has approved suzetrigine (Journavx – Vertex), a selective sodium channel blocker, for oral treatment of moderate to severe acute pain in adults. Suzetrigine is the first sodium channel blocker to be approved in the US for this indication and the first oral nonopioid drug to be approved for treatment of pain in over 25 years.

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Ozempic – Novo Nordisk) has been approved by the FDA to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). It is the first GLP-1 receptor agonist to be approved in the US for this indication.

The FDA has approved lanadelumab-flyo (Takhzyro – Takeda), a subcutaneously-administered plasma kallikrein inhibitor, for prevention of hereditary angioedema (HAE) attacks in adults and children ≥12 years old. Lanadelumab is the third drug to be approved for this indication; the human plasmaderived C1 esterase inhibitors (C1INHs) Cinryze, which is administered IV, and Haegarda, which is given SC, have been available for years for HAE prophylaxis in patients ≥6 years old.