The FDA has approved Durlaza (New Haven Pharmaceuticals), a 24-hour extended-release (ER) aspirin formulation available only by prescription, for secondary prevention of myocardial infarction (MI) and stroke.

The American College of Obstetricians and Gynecologists (ACOG) and the US Preventive Services Task Force (USPSTF) have recommended that women at risk for preeclampsia take low-dose aspirin daily after the first trimester.

The FDA has required manufacturers of the oral P2Y₁₂ platelet inhibitors clopidogrel (Plavix, and generics), prasugrel (Effient, and generics), and ticagrelor (Brilinta) to warn in the product labels that the absorption of these drugs may be delayed or reduced when taken with an opioid agonist.

Dichlorphenamide (Keveyis – Taro), an oral carbonic anhydrase inhibitor, has been approved by the FDA for treatment of primary hypokalemic and hyperkalemic periodic paralysis and related variants. Dichlorphenamide is the first drug to be approved in the US for this indication. It was approved as Daranide in 1958 for treatment of glaucoma, but had not been marketed since 2002.

The FDA has approved an over-the-counter (OTC) liquid-filled capsule formulation of aspirin (Vazalore – PLx Pharma). The manufacturer has been heavily promoting Vazalore with claims of fast, predictable absorption and antiplatelet activity and improved gastrointestinal safety compared to existing OTC aspirin formulations.

Recent guidelines from the American Heart Association and American Stroke Association reviewed antithrombotic therapy options for secondary prevention of stroke in patients who have had a stroke or transient ischemic attack (TIA).

The FDA has approved vorapaxar (Zontivity – Merck), an oral protease-activated receptor-1 (PAR-1) antagonist, for use with aspirin and/or clopidogrel to reduce the risk of thrombotic cardiovascular events in patients with peripheral arterial disease or a history of myocardial infarction (MI). It is the first PAR-1 antagonist to be approved by the FDA.

The FDA has approved Vivlodex (Iroko), a low-dose formulation of the nonsteroidal anti-inflammatory drug meloxicam (Mobic, and generics), for management of osteoarthritis pain. According to the manufacturer, the new formulation aligns with stronger FDA warnings about the cardiovascular risks of NSAIDs and the recommendation to use the lowest possible doses of these drugs.

The FDA has approved a 1.5% topical foam formulation of minocycline (Zilxi – Foamix) for treatment of inflammatory lesions of rosacea in adults. It is the only topical minocycline product approved for this indication. The same manufacturer markets minocycline foam 4% (Amzeeq) for treatment of acne in patients ≥9 years old.

The FDA has approved edoxaban (Savaysa – Daiichi Sankyo), a once-daily, oral, direct factor Xa inhibitor, for treatment of venous thromoboembolism (VTE) and for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is the fourth new oral anticoagulant to be approved for VTE and nonvalvular atrial fibrillation.