Apomorphine (Apokyn - Mylan/Bertek), an injected non-ergot dopamine agonist, was recently approved by the FDA for intermittent subcutaneous (SC) treatment of hypomobility ("off" episodes) in patients with advanced Parkinson's disease. It has been available in Europe for many years.

The FDA has approved an inhaled, rapid-acting, dry-powder formulation of recombinant human insulin (Afrezza – Mannkind/Sanofi) for treatment of adults with type 1 or type 2 diabetes. In patients with type 1 diabetes, the drug must be used in combination with long-acting insulin. Another inhaled, rapid-acting insulin (Exubera) was approved in 2006 for the same indication, but was withdrawn from the market the following year.

The FDA has approved Fiasp (Novo Nordisk), a new formulation of insulin aspart, to improve glycemic control in adults with diabetes. Fiasp is described by the manufacturer as faster-acting than conventional insulin aspart (Novolog).

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 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 injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy) has received accelerated approval from the FDA for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH; previously known as nonalcoholic steatohepatitis [NASH]) with moderate to advanced liver fibrosis in adults. It is the second drug and the first GLP-1 receptor agonist to be approved in the US for treatment of MASH; resmetirom (Rezdiffra), a thyroid hormone receptor-beta agonist, was granted accelerated approval for the same indication in 2024.

Altretamine (Hexalen - US Bioscience; Hexastat - Rh ne-Poulenc in Canada), formerly known only by its chemical name, hexamethylmelamine, was recently approved by the US Food and Drug Administration as a single agent for palliative oral treatment of persistent or recurrent ovarian cancer.

Thalidomide is now available as an investigational drug in the USA. A synthetic derivative of glutamic acid, it was marketed in Europe in 1957 as a sedative but withdrawn four years later after being associated with severe human teratogenicity (PF DArcy and JP Griffin, Adverse Drug React Toxicol Rev, 13:65, 1994). The drug has since been found effective for several different indications.

The FDA has approved the marketing of an extended-release formulation of trazodone (Oleptro – Angelini Labopharm) for treatment of major depressive disorder in adults. Immediate-release trazodone has been available for treatment of depression for many years, but is used mostly in low doses for its sedating effects.

Previously approved by the FDA for treatment of depression, general anxiety disorder, diabetic peripheral neuropathic pain and fibromyalgia, duloxetine (Cymbalta – Lilly) has now also been approved for treatment of chronic musculoskeletal pain.