A new pentavalent vaccine (Pediarix - GlaxoSmithKline), licensed by the FDA for children 6 weeks to 7 years old, includes the antigens from vaccines already marketed against diphtheria, tetanus and pertussis (Infanrix) and hepatitis B (Engerix-B), and a new inactivated polio component.

A device that stimulates the vagus nerve was approved by the FDA in July 1997 for treatment of refractory epilepsy and is now considered "approvable" for treatment-resistant depression.

Some Medical Letter consultants have suggested that our recent article on dermal fillers (Med Lett Drugs Ther 2007; 49:39) should have included stronger warnings about the risk of fillers that are not biodegradable, such as Artefill. The polymethylmethacrylate (PMMA, the same material that makes up Plexiglas) beads in Artefill can over time, even with the best technique, cause foreignbody granulomas and hypertrophic scarring, which may require surgical removal. Granulomas and nodules have been especially frequent when Artefill was injected into the lips. Complications are less likely with...

The FDA has approved pembrolizumab (Keytruda – Merck), a human programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed following treatment with ipilimumab (Yervoy) and, if the patient is BRAF V600 mutation positive, a BRAF inhibitor. It is the fi rst PD-1 inhibitor to be marketed in the US. Nivolumab, another PD-1 inhibitor, is available in Japan. Pembrolizumab was previously known as lambrolizumab.

The FDA has approved tavaborole 5% solution (Kerydin – Anacor Pharmaceuticals) for topical treatment of toenail onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes. It is the first oxaborole antifungal drug to be approved for this indication.

The FDA has approved pomalidomide (Pomalyst – Celgene), an oral thalidomide analog, for treatment of patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide (Revlimid) and bortezomib (Velcade) and whose disease had progressed on or within 60 days of completion of the last therapy.

The FDA recently approved ixazomib (Ninlaro – Takeda), daratumumab (Darzalex – Janssen Biotech), and elotuzumab (Empliciti – BMS) for treatment of relapsed and/or refractory multiple myeloma.

The CDC has issued new guidance allowing for an interval of up to 8 weeks between the first and second primary doses of an mRNA COVID-19 vaccine in certain patients 12-64 years old.1 Product labeling currently recommends a 3-week interval between the first two doses of the Pfizer/BioNTech mRNA vaccine (Comirnaty) and a 4-week interval between the first two doses of the Moderna mRNA vaccine (Spikevax). The new guidance is based on data suggesting that a longer interval can decrease the risk of myocarditis and may improve vaccine efficacy.

Tapinarof 1% cream (Vtama – Dermavant), an aryl hydrocarbon receptor (AhR) agonist, has been approved by the FDA for topical treatment of atopic dermatitis in patients ≥2 years old. Tapinarof is the first AhR agonist to be approved in the US for this indication. It was approved in 2022 for treatment of plaque psoriasis in adults.

Omeprazole (Losec - Merck), a new drug that suppresses gastric acid secretion, has been approved by the US Food and Drug Administration for short-term (four to eight weeks) treatment of severe or refractory gastroesophageal reflux and for long-term treatment of pathological hypersecretory conditions such as Zollinger-Ellison syndrome, multiple endocrine adenomas, and systemic mastocytosis. Although widely used abroad for treatment of peptic ulcers, it has not been approved for that indication in the USA.