A recent article in JAMA and an interview of its senior author on 60 Minutes have heightened interest in off-label use of the oral selective serotonin reuptake inhibitor (SSRI) fluvoxamine (Luvox, and generics) to treat COVID-19.

The FDA has approved RiVive (Harm Reduction Therapeutics), a 3-mg naloxone nasal spray, as an over-the-counter (OTC) product for emergency treatment of opioid overdose. Two 4-mg naloxone nasal spray formulations, Narcan and one of its generics, were approved for OTC sale in 2023.

The FDA has approved Erzofri (Luye), an extended-release injectable formulation of the second-generation antipsychotic drug paliperidone palmitate, for treatment of schizophrenia and schizoaffective disorder in adults. It is the second once-monthly formulation of paliperidone palmitate to be approved in the US for these indications; Invega Sustenna was the first. Longer-acting injectable formulations of paliperidone palmitate are also available (see Table 1).

The FDA has issued an Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to be administered concomitantly by IM injection for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of severe allergy that prevents their vaccination against COVID-19 or moderate or severe immune compromise (see Table 1). They are the first drugs to be authorized by the FDA for this indication. Two other pairs of antibodies, bamlanivimab plus etesevimab...

The oral second-generation antipsychotic drug lumateperone (Caplyta – Intra-Cellular Therapies), which was approved by the FDA in 2020 for treatment of schizophrenia, is now approved for use as monotherapy or as an adjunct to lithium or valproate for treatment of depressive episodes associated with bipolar I or II disorder in adults.

The FDA has approved a 12.45% gel formulation of the anticholinergic drug sofpironium (Sofdra – Botanix) for treatment of primary axillary hyperhidrosis (excessive underarm sweating) in patients ≥9 years old.

The FDA has expanded its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use in children as young as 6 months old. The Pfizer vaccine was previously authorized for use in persons ≥5 years old, and the Moderna vaccine was authorized for use in adults ≥18 years old.

The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for treatment of eosinophilic esophagitis (EoE) in patients ≥12 years old who weigh ≥40 kg and treatment of prurigo nodularis in adults. Dupilumab is the first drug to be approved in the US for each of these indications. It is also FDA-approved for treatment of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.

Primary hypothyroidism is usually the result of Hashimoto's (autoimmune) thyroiditis, thyroidectomy, or radioactive iodine therapy. Treatment of hypothyroidism with replacement doses of thyroid hormone is usually lifelong. Levothyroxine (LT4; synthetic thyroxine; Synthroid, and others) is the drug of choice.1

The FDA has approved Phexxi (Evofem), a nonhormonal prescription-only vaginal gel containing lactic acid, citric acid, and potassium bitartrate, for prevention of pregnancy. The gel is intended for on-demand contraception; it is not effective when used after intercourse. It was previously approved for use as a vaginal lubricant (Amphora), but was never marketed.