On January 3, the FDA amended its Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) to incorporate the following changes. The anti-SARS-CoV-2 antibody combinations casirivimab plus imdevimab (REGEN-COV) and bamlanivimab plus etesevimab are not active against the Omicron variant of SARS-CoV-2.

Treatment of community-acquired pneumonia (CAP) is usually empiric, with selected antibiotic regimens directed against some of the most common causative pathogens. Recommended empiric regimens are listed in Table 2; recommended antibiotic dosages for treatment of CAP are listed in Tables 3 and 4. Joint guidelines for treatment of CAP by the American Thoracic Society and the Infectious Diseases Society of America (ATS/IDSA) were updated in 2019.

Pharmacologic management of chronic heart failure (HF) is primarily determined by the patient's left ventricular ejection fraction (LVEF) and severity of symptoms. Patients with chronic HF who have an LVEF ≤40% are considered to have heart failure with reduced ejection fraction (HFrEF) and those with an LVEF ≥50% are considered to have heart failure with preserved ejection fraction (HFpEF). Patients with an LVEF of 41-49% have heart failure with mildly reduced or mid-range ejection fraction.

View the Comparison Chart: Some Drugs for HFrEF

The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include use of the vaccine as a two-dose primary series in adolescents 12-17 years old. The vaccine was authorized for primary immunization of adults in July 2022.

The possibility that use of mifepristone (Mifeprex, and generics) may be restricted has led to questions about alternatives for medication abortion.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin has been available for years alone (Jardiance – Boehringer Ingelheim) and in combination with metformin (Synjardy) to improve glycemic control in adults with type 2 diabetes. Both products have now been approved for use in children ≥10 years old. Empagliflozin is the second oral drug to become available in the US for treatment of type 2 diabetes in children; metformin has been available since 2000 for this indication. The injectable glucagon-like peptide-1 (GLP-1) receptor agonists liraglutide (Victoza) and...

Omlyclo (omalizumab-igec; Celltrion), a biosimilar product interchangeable with the recombinant anti-IgE monoclonal antibody Xolair, has been approved by the FDA for same indications as Xolair (see Table 1). Omlyclo is the first Xolair biosimilar to be approved in the US.

Aducanumab-avwa (Aduhelm – Biogen/Eisai), an IV amyloid beta-directed monoclonal antibody, has received accelerated approval from the FDA for treatment of Alzheimer's disease. The approval was based on the surrogate endpoint of reduction in amyloid beta plaques in the brain. The manufacturer is required to conduct an additional randomized controlled trial to establish that reducing amyloid beta plaques with aducanumab improves clinical outcomes in patients with Alzheimer's disease.

The FDA has approved a higher-dose injectable formulation of the opioid antagonist naloxone (Zimhi – Adamis) for emergency treatment of opioid overdose. A single IM or SC injection of the new formulation delivers 5 mg of naloxone; injectable formulations that deliver 0.4 mg or 2 mg of the drug have been available for years. Naloxone is also available in intranasal formulations for the same indication (see Table 1).