Vyalev (Abbvie), a solution for continuous subcutaneous infusion containing the prodrugs foscarbidopa and foslevodopa, has been approved by the FDA for treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). Vyalev is the first subcutaneously administered product to become available in the US for treatment of PD symptoms. Duopa, a carbidopa/levodopa enteral suspension infused via a nasojejunal tube or percutaneous gastrostomy, was approved in for the same indication 2015.

Miudella (Sebela), a copper intrauterine device (IUD), has been approved by the FDA for prevention of pregnancy for up to 3 years. Miudella is the second copper IUD to be approved in the US; ParaGard, which contains more copper and is approved for up to 10 years of use, was approved in 1984. Four hormonal IUDs (Mirena, Liletta, Skyla, Kyleena) that release the progestin levonorgestrel are also available for pregnancy prevention (see Table 2).

When used for the appropriate seizure type, antiseizure medications (ASMs) are roughly equivalent in efficacy. In addition to the seizure type, the choice of drug is usually based on factors such as ease of use, spectrum of activity, adverse effects, interactions with other drugs, presence of comorbid conditions, suitability for elderly persons and those with childbearing potential, and cost. Treatment should begin with a single drug, increasing the dosage gradually until seizures are controlled or adverse effects become unacceptable. If seizures persist, expert clinicians generally...

The recombinant interleukin-1 (IL-1) receptor antagonist anakinra (Kineret – Sobi) has been granted an FDA Emergency Use Authorization (EUA) for treatment of hospitalized adults with confirmed COVID-19 pneumonia who require low- or high-flow supplemental oxygen, are at risk of progressing to severe respiratory failure, and are likely to have elevated plasma levels of soluble urokinase plasminogen activator receptor (suPAR). Anakinra has been available in the US for years; it is FDA-approved for multiple indications, including rheumatoid arthritis. Assays for suPAR are...

Voclosporin (Lupkynis – Aurinia), an oral calcineurin inhibitor, has been approved by the FDA for use in combination with the antimetabolite immunosuppressant mycophenolate mofetil (Cellcept, and generics) and a corticosteroid for treatment of adults with active lupus nephritis. It is the first calcineurin inhibitor to be approved in the US for this indication. Tacrolimus (Prograf, and others) and cyclosporine (Neoral, and others), the other available systemic calcineurin inhibitors, are approved for prophylaxis of organ rejection in transplant patients.

The FDA has approved dasiglucagon (Zegalogue – Zealand) for subcutaneous (SC) treatment of severe hypoglycemia in patients ≥6 years old with diabetes. Dasiglucagon is the third glucagon product to be marketed in the US that does not require reconstitution before administration; Gvoke, a SC formulation approved for use in patients ≥2 years old, and Baqsimi, an intranasal powder approved for use in patients ≥4 years old, have been available since 2019. Injectable glucagon emergency kits (GlucaGen HypoKit, and generics) have been available for years, but they require...

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 1.5% cream formulation of the Janus kinase (JAK) inhibitor ruxolitinib (Opzelura – Incyte) has been approved by the FDA for topical treatment of nonsegmental vitiligo (NSV) in patients ≥12 years old. Opzelura is the first product to be approved by the FDA for this indication. It was previously approved for treatment of atopic dermatitis.

The FDA has approved oral and injectable formulations of the HIV-1 capsid inhibitor lenacapavir (Sunlenca – Gilead) for use with other antiretroviral drugs to treat multidrug-resistant HIV-1 infection (MDR-HIV) in heavily treatment-experienced adults whose current regimen is failing. Lenacapavir is the third drug to be approved exclusively for treatment of MDR-HIV; the intravenously administered CD4-directed antibody ibalizumab-uiyk (Trogarzo) and the orally administered HIV-1 gp120-directed attachment inhibitor fostemsavir (Rukobia) were approved earlier.

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.