The FDA has required the manufacturers of the mRNA COVID-19 vaccines Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna) to revise their labels to include updated information about the risks of myocarditis/pericarditis. The FDA requested that the manufacturers submit the proposed labeling changes or contest the agency's requirement for the safety update by May 17, 2025. As of June 4th, to our knowledge, the labels of Comirnaty and Spikevax have not been updated and neither manufacturer has submitted a rebuttal.

The FDA has approved a new 550-mg tablet of rifaximin (Xifaxan – Salix), a minimally absorbed oral antibiotic, to reduce the risk of recurrent hepatic encephalopathy (HE). A 200-mg tablet has been available for treatment of travelers’ diarrhea since 2004.

The FDA has approved a new IV formulation of dantrolene (Ryanodex – Eagle) for prevention and treatment of malignant hyperthermia in adults and children. The new formulation requires fewer vials, less fluid volume, and less time for preparation and administration than other available IV dantrolene products (Dantrium, Revonto).

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.

In Table 1 of our February 1, 2016 article Drugs for Acne (Med Lett Drugs Ther 2016; 58:13), the formulations for Differin, topical adapalene, should have been listed as 0.1% gel, cream, lotion; 0.3% gel (not 3% gel).

Estazolam (ProSom - Abbott), a triazolobenzodiazepine derivative similar in structure to alprazolam (Xanax) and triazolam (Halcion), was recently marketed in the USA for treatment of insomnia.

The well-publicized recovery from paralysis of a professional football player has recently focused attention on the growing use of drugs to minimize the effects of spinal cord injury. Methylprednisolone sodium succinate (Solu-Medrol - Upjohn), commercially available in the USA for intravenous treatment of transplant rejection and various inflammatory and auto-immune disorders, and GM-1 ganglioside, commercially available in Italy (Sygen - Fidia) but not in the USA, are now widely used in patients with spinal cord injury.