The FDA has approved a higher-dose intranasal naloxone formulation (Kloxxado – Hikma) for emergency treatment of opioid overdose. A single spray of the new formulation delivers 8 mg of naloxone; a formulation that delivers 4 mg per spray (Narcan) was approved in 2015.

The FDA has approved Verkazia (Santen), a 0.1% ophthalmic emulsion formulation of the calcineurin inhibitor cyclosporine, for treatment of vernal keratoconjunctivitis (VKC). Verkazia is the first product to be approved in the US for this indication.

Two recombinant vaccines, Arexvy (GSK) and Abrysvo (Pfizer), have been approved by the FDA for prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults ≥60 years old. They are the first RSV vaccines to be approved in the US. Abrysvo is also approved for use in pregnant women at 32-36 weeks' gestation to prevent LRTD caused by RSV in their infants from birth through 6 months of age.

A transdermal formulation of the second-generation (atypical) antipsychotic asenapine (Secuado – Noven) has been approved by the FDA for once-daily treatment of schizophrenia in adults. Asenapine is the first antipsychotic to become available in a transdermal formulation in the US. A twice-daily sublingual tablet formulation of asenapine (Saphris) has been available since 2009.

The FDA has issued an Emergency Use Authorization (EUA) for the long-acting investigational IV monoclonal antibody pemivibart (Pemgarda – Invivyd) for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old (weight ≥40 kg) who have moderate to severe immune compromise and are unlikely to respond adequately to COVID-19 vaccination (see Table 1). Pemgarda is the only drug that is currently authorized in the US for pre-exposure prophylaxis of COVID-19. Tixagevimab/cilgavimab (Evusheld) was previously available under an EUA for this indication, but it lacks activity against...

The FDA has approved changes to the labeling of Sublocade (Indivior), an extended-release formulation of the partial opioid agonist buprenorphine, to permit faster initiation and use of alternative injection sites. Sublocade is indicated for once-monthly subcutaneous treatment of moderate to severe opioid use disorder.

The labeling for the investigational, long-acting, prophylactic anti-SARS-CoV-2 monoclonal antibodies tixagevimab and cilgavimab (Evusheld; available under an FDA Emergency Use Authorization) now includes warnings about a risk of serious hypersensitivity reactions, including anaphylaxis, with use of the drugs, particularly in patients who have experienced a hypersensitivity reaction to a COVID-19 vaccine.

The FDA has expanded its Emergency Use Authorization for the mRNA COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to include administration of a booster dose in children 5-11 years old who completed a primary series of the Pfizer vaccine ≥5 months previously.

Disruption of tear-film homeostasis (altered composition, reduced production, rapid evaporation) and resulting ocular surface inflammation cause the discomfort and blurred vision of dry eye disease. Many cases are caused by tear evaporation due to meibomian gland dysfunction. Other precipitating factors can include lacrimal gland dysfunction, poor eyelid function, environmental factors, extended screen time, inflammatory conditions such as Sjögren's syndrome, and use of some ocular or systemic drugs such as antihistamines, retinoids, or selective serotonin reuptake inhibitors...

The FDA has approved the over-the-counter (OTC) sale of Narcan (Emergent), a nasal spray that delivers 4 mg of the opioid antagonist naloxone. Narcan nasal spray has been available by prescription since 2015 for emergency treatment of opioid overdose. Generic formulations of Narcan have also been approved; the manufacturers of these products will be required to switch them to OTC status and amend their labeling accordingly. Kloxxado, an 8-mg naloxone nasal spray, remains available only by prescription.