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The package inserts of the GLP-1 receptor agonists dulaglutide (Trulicity), exenatide (Byetta, Bydureon BCise), liraglutide (Saxenda, Victoza), and semaglutide (Ozempic, Rybelsus, Wegovy) and the dual glucosedependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist tirzepatide (Mounjaro, Zepbound) have been updated to include rare postmarketing reports of pulmonary aspiration associated with their use in patients undergoing elective surgery or other procedures requiring general anesthesia or deep sedation who had residual gastric contents despite preoperative fasting.

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.

Obecabtagene autoleucel (Aucatzyl – Autolus), a CD19-directed genetically modified autologous T cell immunotherapy, has been approved by the FDA for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. The CAR T-cell immunotherapy products tisagenlecleucel (Kymriah) and brexucabtagene auto-leucel (Tecartus) were approved earlier for the same indication.

Age-related macular degeneration (AMD) has two major forms: dry or non-neovascular (~90% of patients) and wet or neovascular (~10% of patients).

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.

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.

Elafibranor (Iqirvo – Ipsen), a peroxisome proliferator-activated receptor (PPAR) agonist, has been granted accelerated approval by the FDA for treatment of primary biliary cholangitis (PBC) in adults. It is indicated for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso, and others) in patients with an inadequate response to UDCA alone and as monotherapy in those unable to tolerate UDCA.

The FDA has approved pilocarpine 0.4% preservativefree ophthalmic solution (Qlosi – Orasis) for treatment of presbyopia in adults. Pilocarpine 1.25% ophthalmic solution (Vuity) was approved in 2021 for the same indication. Pilocarpine 1%, 2%, and 4% ophthalmic solutions (Isopto Carpine, and others) have been available for years for treatment of glaucoma, but local (e.g., blurry vision and instillation-site pain) and systemic (e.g., sweating and GI disturbances) adverse effects have limited their use.

Revumenib (Revuforj – Syndax), an oral menin inhibitor, has been approved by the FDA for treatment of relapsed or refractory acute leukemia in patients ≥1 year old with a lysine methyltransferase 2A gene (KMT2A) translocation. It is the first menin inhibitor to be approved in the US.

The FDA has approved Crexont (Amneal), an extended-release capsule formulation of carbidopa/levodopa, for treatment of Parkinson's disease (PD), postencephalitic parkinsonism, and parkinsonism associated with carbon monoxide or manganese intoxication. Crexont contains a combination of immediate-release carbidopa/levodopa granules and extended-release levodopa pellets. An extended-release carbidopa/levodopa oral capsule (Rytary) has been available from the same manufacturer for years; the patent for Rytary expires in 2025.