The FDA has approved Xultophy 100/3.6 (Novo Nordisk), a fixed-ratio combination of insulin degludec and the GLP-1 (glucagon-like peptide-1) receptor agonist liraglutide, for once-daily treatment of adults with type 2 diabetes inadequately controlled on basal insulin (<50 units daily) or liraglutide (≤1.8 mg daily).

View the Comparison Table: Some Drugs for Migraine Prevention in Adults

On September 22, on the advice of its Vaccines and Related Biologic Products Advisory Committee, the FDA expanded the Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine (Comirnaty) to include administration of a booster dose ≥6 months after a 2-dose primary series in adults who are ≥65 years old or at high risk for severe COVID-19 because of an underlying medical condition or frequent institutional or occupational exposure to SARS-CoV-2 (see Table 1). The FDA Advisory Committee recommended against authorization of a booster dose of Comirnaty...

Lonapegsomatropin-tcgd (Skytrofa – Ascendis), a long-acting prodrug of recombinant human growth hormone (rhGH), has been approved by the FDA for once-weekly subcutaneous (SC) treatment of growth failure due to inadequate secretion of endogenous growth hormone in children ≥1 year old who weigh ≥11.5 kg. It is the first once-weekly rhGH product to be approved in the US; other available rhGH formulations are administered more frequently.

Acupuncture is the practice of inserting fine needles for therapeutic purposes into points on the skin known as acupoints. In traditional Chinese medicine theory, these points arefound along channels that conduct "qi" (pronounced "chee"), or energy. In addition to insertion of needles, acupoints can be stimulated by heat, electrical current or just pressure.

A transdermal patch formulation of methylphenidate (Daytrana - Noven/Shire) has been approved by the FDA for treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥ 6 years old. Like other methylphenidate products, the patch is a schedule II controlled substance. According to the manufacturer, it will be available in pharmacies by the end of June.

Nabilone, an oral synthetic cannabinoid similar to delta-9-tetrahydrocannabinol (THC), the active ingredient in marijuana, has recently been reintroduced to the US market (Cesamet - Valeant) after a 17-year absence. The previous manufacturer discontinued marketing of the drug for commercial reasons. Nabilone is classified as a Schedule II controlled substance.

Dapagliflozin (dap" a gli fl oe' zin; Farxiga – Bristol-Myers Squibb/AstraZeneca), an SGLT2 (sodium-glucose co-transporter 2) inhibitor, has been approved by the FDA for oral treatment of type 2 diabetes. Dapagliflozin is the second SGLT2 inhibitor to be approved for this indication; canagliflozin (Invokana) was the first .

The FDA has approved Jornay PM (Ironshore), a capsule formulation of methylphenidate with a delayed-release outer layer and an extended-release inner layer, for once-nightly treatment of attention-deficit hyperactivity disorder (ADHD) in patients >6 years old. Jornay PM is the first methylphenidate product to become available in the US that is taken in the evening; other long-acting methylphenidate formulations are taken in the morning. It is being marketed specifically for patients who have disruptive ADHD symptoms in the morning.

The FDA has approved opicapone (Ongentys – Neurocrine), a peripherally-acting reversible catechol-O-methyltransferase (COMT) inhibitor, for oral use as an adjunct to carbidopa/levodopa in adults with Parkinson’s disease (PD) who experience "off" episodes. It is the third COMT inhibitor to be approved for this indication; tolcapone (Tasmar, and generics) and entacapone (Comtan, and generics) were approved earlier. Opicapone has been available in Europe since 2016.