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New 2024-2025 formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) that more closely target currently circulating variants have been licensed by the FDA for persons ≥12 years old and made available under FDA Emergency Use Authorizations (EUAs) for use in persons 6 months to 11 years old.1-3 A 2024-2025 formulation of the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax is expected to become available soon for persons ≥12 years old.

Annual vaccination in the US against influenza A and B viruses is recommended for everyone ≥6 months old without a contraindication. Influenza vaccines available in the US for the 2024-2025 season are listed in Table 2.

The main goals of treatment of chronic obstructive pulmonary disease (COPD) are to relieve symptoms, reduce the frequency and severity of exacerbations, prevent disease progression, and reduce mortality. GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines for treatment of COPD were updated recently. Treatment of acute exacerbations is not discussed here. Drugs available for treatment of COPD are listed in Tables 1 and 3.

The adeno-associated virus (AAV) vector-based gene therapy delandistrogene moxeparvovec-rokl (Elevidys – Sarepta) received accelerated approval from the FDA in 2023 for treatment of ambulatory children 4-5 years old with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the DMD gene. It has now received full approval for use in ambulatory patients ≥4 years old and accelerated approval for use in nonambulatory patients with DMD.

The FDA has approved Soaanz (Sarfez), a new formulation of the loop diuretic torsemide, for treatment of edema associated with heart failure or renal disease in adults. Torsemide has been available generically for years for treatment of hypertension and treatment of edema due to heart failure, renal disease, or hepatic disease. According to the manufacturer, Soaanz tablets are formulated to provide a gradual and sustained diuresis, lowering the risk of excessive urination and hypokalemia.

The short-acting formulation of mixed amphetamine salts (Adderall, and generics) FDA-approved for treatment of attention-deficit hyperactivity disorder (ADHD) and narcolepsy, is currently in short supply in the US. Until an adequate supply is restored, patients may be looking for alternatives.

View the Comparison Table: Inhaled Drugs for Treatment of COPD

Topical ivermectin lotion 0.5% (Sklice, and generics), which has been available by prescription since 2012, is now FDA-approved for sale over the counter (OTC) for treatment of head lice in patients ≥6 months old. Ivermectin is also available by prescription as a 1% cream (Soolantra) approved for topical treatment of inflammatory lesions of rosacea and in oral tablets (Stromectol, and generics) for treatment of various parasitic infections.

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 earlier this year for commercial reasons.

The FDA has approved a 0.15% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of mild to moderate atopic dermatitis (AD) in patients ≥6 years old. Roflumilast is the second PDE4 inhibitor to be approved in the US for treatment of AD; crisaborole (Eucrisa), which can be used in patients ≥3 months old, was the first. Roflumilast is available as Zoryve in a 0.3% cream for treatment of plaque psoriasis and a 0.3% foam for treatment of seborrheic dermatitis. It is also available in an oral formulation (Daliresp) for treatment of chronic obstructive pulmonary disease.