Atrial fibrillation increases the risk of thromboembolic stroke. Anticoagulant therapy can reduce this risk and is recommended for patients with atrial fibrillation and one or more of the following: congestive heart failure, hypertension, age ≥75 years, diabetes, or prior stroke or transient ischemic attack (CHADS₂ score ≥1).

The FDA has approved a once-daily, extended-release oral suspension of methylphenidate (Quillivant XR – Pfizer) for treatment of attention-deficit/hyperactivity disorder (ADHD). It is the first liquid formulation of the drug to be marketed for once-daily use. A short-acting oral solution (Methylin, and generics) has been available since 2003.

The FDA has approved two new long-acting injectable formulations of second-generation antipsychotics for treatment of schizophrenia: aripiprazole lauroxil (Aristada – Alkermes), which is given once every 4-6 weeks, and paliperidone palmitate (Invega Trinza – Janssen), which is given once every 3 months. Once-monthly injectable formulations of aripiprazole (Abilify Maintena) and paliperidone palmitate (Invega Sustenna) were approved earlier.

The FDA has approved reslizumab (Cinqair – Teva), a humanized interleukin-5 (IL-5) antagonist monoclonal antibody, for add-on maintenance treatment of severe asthma in adults who have an eosinophilic phenotype. It is the second IL-5 antagonist to be approved in the US; mepolizumab (Nucala) was approved for the same indication in 2015.

The oral adenosine triphosphate-citrate lyase (ACL) inhibitor bempedoic acid was approved by the FDA in 2020 for use alone (Nexletol – Esperion) and in a fixed-dose combination with the cholesterol absorption inhibitor ezetimibe (Nexlizet) as an adjunct to maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional LDL-cholesterol (LDL-C) lowering. The indication has now been expanded to include reducing the risk of myocardial infarction (MI) and coronary...

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.

Saw palmetto, an "herbal supplement,"is now being heavily promoted to the general public for treatment of urinary symptoms related to prostatic enlargement. It has not been approved for any use by the FDA.

The labeling of dabigatran etexilate (Pradaxa – Boehringer Ingelheim), an oral direct thrombin inhibitor, has recently been updated to include new dosing and monitoring recommendations and a warning on the risk of bleeding. Dabigatran etexilate was approved in the US in 2010 for the prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation. It has been shown to be more effective than warfarin (Coumadin, and others) for this indication.

Pancreatic enzyme replacement products have been used for years to improve digestion in patients with exocrine pancreatic insufficiency (EPI). These products were initially marketed before formal FDA approval was required; in 1991, however, the FDA told all manufacturers of pancreatic enzyme replacement products that they would have to submit a new drug application by April 2010 in order to keep their products on the market.EPI is a chronic disorder characterized by a deficiency of exocrine pancreatic enzymes, which results in malabsorption, steatorrhea, and weight loss. Irreversible EPI is...

Olutasidenib (Rezlidhia – Rigel), an oral isocitrate dehydrogenase-1 (IDH1) inhibitor, has been approved by the FDA for treatment of relapsed or refractory acute myeloid leukemia (AML) in adults with a susceptible IDH1 mutation. It is the second drug that targets cancer metabolism to be approved for this indication; ivosidenib (Tibsovo) was approved in 2022.