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.

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.

Tapinarof 1% cream (Vtama – Dermavant), an aryl hydrocarbon receptor (AhR) agonist, has been approved by the FDA for topical treatment of atopic dermatitis in patients ≥2 years old. Tapinarof is the first AhR agonist to be approved in the US for this indication. It was approved in 2022 for treatment of plaque psoriasis in adults.

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).

Inclisiran (Leqvio – Novartis), a subcutaneously injected small interfering RNA (siRNA) that decreases LDL-cholesterol (LDL-C) levels by reducing synthesis of proprotein convertase subtilisin/kexin type 9 (PCSK9), has been approved by the FDA for use with or without a statin to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Inclisiran had previously been approved for use only in combination with statin therapy.

Auvelity (Axsome), an extended-release fixed-dose combination of dextromethorphan and bupropion that was approved by the FDA for treatment of major depressive disorder in 2022, has now been approved for treatment of agitation associated with dementia due to Alzheimer's disease (AD). It is the second product to be approved in the US for this indication; the oral second-generation antipsychotic drug brexpiprazole (Rexulti) was approved in 2023.

The FDA has approved Omlonti (Ocuvex), a 0.002% ophthalmic solution of the prostaglandin EP₂ receptor agonist omidenepag isopropyl, for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Omidenepag is the first selective prostaglandin EP₂ receptor agonist to be approved in the US. It has been available in Japan since 2018.

The FDA has approved Prestalia (Symplmed), an oral fixed-dose combination of the dihydropyridine calcium channel blocker amlodipine (Norvasc, and generics) and a new salt form of the angiotensin-converting enzyme (ACE) inhibitor perindopril, for treatment of hypertension in patients not adequately controlled on monotherapy or already taking both drugs, and in those just starting therapy who are likely to need multiple drugs to control their blood pressure. The new salt form (perindopril arginine) is more stable and has a longer shelf-life than perindopril erbumine (Aceon, and...

A patient-controlled fentanyl iontophoretic transdermal system (Ionsys – The Medicines Company) is now available for short-term management of acute postoperative pain in adults requiring opioid analgesia in the hospital. Before using Ionsys, patients must be titrated to a comfortable level of analgesia with another opioid formulation.

The FDA has approved insulin degludec (Tresiba – Novo Nordisk) for treatment of adults with type 1 or type 2 diabetes. Insulin degludec is the third long-acting human insulin analog to be approved by the FDA; insulin detemir (Levemir) and insulin glargine (Lantus, Toujeo) were approved earlier.