Sermorelin acetate, a synthetic form of human growth-hormone-releasing factor has been approved by the FDA for treatment of idiopathic growth hormone deficiency in children with growth failure.

The FDA has approved a lingual aerosol formulation of nitroglycerin (NitroMist – Akrimax) for acute relief of an attack or acute prophylaxis of angina pectoris. It is the second nitroglycerin lingual spray to become available in the US; Nitrolingual Pumpspray was approved in 1985. Most patients with angina use sublingual nitroglycerin tablets.

Even though it is unlikely that people living in the US will be at risk of significant radiation exposure from the nuclear accident in Japan, some readers have suggested a review of the use of potassium iodide (KI) in such circumstances. Potassium iodide taken orally before or at the time of exposure can limit or prevent uptake of radioactive iodine by the thyroid gland.

The FDA has approved fixed-dose combinations of metformin with either canagliflozin (Invokamet) or dapagliflozin (Xigduo XR) for treatment of patients with type 2 diabetes not adequately controlled with any one of these drugs, or in those already being treated with both metformin and either canagliflozin or dapagliflozin.

The FDA has approved crisaborole 2% ointment (Eucrisa – Pfizer) for topical treatment of mild to moderate atopic dermatitis in patients ≥2 years old. It is the first phosphodiesterase type-4 (PDE4) inhibitor to be approved in the US for this indication.

Mosunetuzumab-axgb (Lunsumio – Genentech), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of relapsed or refractory follicular lymphoma in adults who received ≥2 lines of systemic therapy. It is the first T-cell-engaging bispecific antibody to be approved in the US for this indication.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga – AstraZeneca) has been approved by the FDA for treatment of adults with chronic kidney disease (CKD) at risk of progression (not defined in the label). Dapagliflozin is the first SGLT2 inhibitor to be approved in the US for treatment of CKD.

The FDA has announced that it is requiring changes in the labeling of the macrolide antibiotic azithromycin (Zithromax, Zmax) to warn about the risk of QT prolongation and cardiac arrhythmias.1 The new warnings are based on a retrospective study in The New England Journal of Medicine (reviewed previously in The Medical Letter2), which found that among patients who received 347,795 prescriptions for azithromycin, there were 29 cardiovascular deaths, a significantly higher rate than the 42 that occurred among patients who received 1,348,672 prescriptions for amoxicillin (which does not prolong...

Nuvaxovid, the adjuvanted protein subunit COVID-19 vaccine marketed by Novavax, has received full approval from the FDA to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in all adults ≥65 years old and in adults 12-64 years old who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. The vaccine was previously available under an FDA Emergency Use Authorization (EUA) for use in persons ≥12 years old.1 Nuvaxovid is the first protein-based COVID-19 vaccine to receive full approval from the...

The goal of drug therapy for type 2 diabetes is to achieve and maintain a near-normal glycated hemoglobin (A1C) concentration without inducing hypoglycemia; for most patients, the target A1C is <7%. Metformin is the preferred first-line treatment, but most patients with type 2 diabetes eventually require multidrug therapy and/or insulin to achieve glycemic control.