The FDA has added a "black box" warning about the risks of QT prolongation and the potentially fatal torsades de pointes (TdP) ventricular tachycardia to the labeling of droperidol (Inapsine - Akorn), an antiemetic used mostly in anesthesia. The Canadian Health Protection Branch has issued a similar warning. Some anesthesiologists have written to The Medical Letter to express their displeasure with these warnings.

Rasburicase (Elitek - Sanofi-Synthelabo), a recombinant form of urate oxidase derived from the fungus Aspergillus flavus, has been approved by the FDA for intravenous (IV) management of hyperuricemia associated with tumor lysis syndrome in pediatric patients.

Anastrozole (Arimidex - AstraZeneca, Medical Letter 1996; 38:61), an aromatase inhibitor, has received accelerated approval from the FDA for adjuvant treatment of postmenopausal women with early hormone-receptor-positive breast cancer. The drug was approved for treatment of postmenopausal women with metastatic breast cancer in 1996.

Cinacalcet hydrochloride (Sensipar - Amgen) has been approved by the FDA for treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis and treatment of hypercalcemia in patients with parathyroid carcinoma.

The FDA has approved an extended-release formulation of clonidine hydrochloride (Kapvay– Shionogi) for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-17 years old. It is the second alpha₂-adrenergic agonist approved for this indication; guanfacine hydrochloride (Intuniv) was the first, but only clonidine is approved for use with stimulants.

Belimumab (Benlysta – Human Genome Sciences/GlaxoSmithKline) has been approved by the FDA for treatment of adults with active, autoantibody-positive, systemic lupus erythematosus (SLE). It is the first biologic agent approved for SLE and the first drug of any kind to be approved for this disease in >50 years.

Palbociclib (Ibrance – Pfizer), an oral cyclin-dependent kinase inhibitor, has been approved by the FDA for use in combination with the aromatase inhibitor letrozole (Femara, and generics) for first-line treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. It is the first cyclin-dependent kinase inhibitor to become available in the US.

The investigational neutralizing IgG1 monoclonal antibody bamlanivimab (LY-CoV555; Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of recently diagnosed mild to moderate COVID-19 in patients who are ≥12 years old, weigh at least 40 kg, and are at high risk for progressing to severe disease and/or hospitalization (see Table 1).

The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has received accelerated approval from the FDA for treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusions or other rearrangements. Pemigatinib is the first drug to be approved in the US for this indication.

Teprotumumab-trbw (Tepezza - Horizon), an insulin-like growth factor-1 receptor (IGF-1R) inhibitor, has been approved by the FDA for IV treatment of thyroid eye disease. It is the first drug to be approved in the US for this indication.