Aprotinin (Trasylol - Miles), an inhibitor of fibrinolysis first identified in 1930, was recently approved by the US Food and Drug Administration for intravenous use in high-risk coronary artery bypass graft (CABG) surgery to decrease bleeding and the need for transfusion. Inhibitors of fibrinolysis previously available in the USA include aminocaproic acid (Amicar, and others) and tranexamic acid (Cyklokapron - Medical Letter, 29:89, 1987).

The angiotensin receptor blocker (ARB) azilsartan medoxomil (Edarbi – Takeda) was recently approved by the FDA for oral treatment of hypertension, either alone or combined with other drugs. It is the eighth ARB approved for this indication.

The FDA has approved an oral solution of the nonselective beta-adrenergic blocker propranolol (Hemangeol – Pierre Fabre) for treatment of proliferating infantile hemangiomas.

Rilonacept (Arcalyst – Kiniksa), an interleukin-1 (IL-1) antagonist that has been available for years for treatment of cryopyrin-associated periodic syndromes, has now been approved by the FDA for treatment of recurrent pericarditis and prevention of further recurrences in patients ≥12 years old. It is the first drug to be approved in the US for this indication. Anakinra (Kineret), an IL-1 receptor antagonist FDA-approved for treatment of rheumatoid arthritis, has been used off-label for years for treatment of recurrent pericarditis.

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.

The FDA has approved Zunveyl (Alpha Cognition), a delayed-release formulation of the prodrug benzgalantamine, for treatment of mild to moderate dementia of Alzheimer's disease (AD). Immediate- and extended-release formulations of the acetylcholinesterase inhibitor galantamine have been available in the US for years for treatment of AD.

In recent years, several new drugs have been approved by the FDA for use in multiple sclerosis (MS), and many others are in the pipeline. Most recently, teriflunomide (Aubagio – Genzyme) became the second oral drug to be approved by the FDA for treatment of relapsing forms of MS.

The FDA has approved ozanimod (Zeposia – Celgene), a sphingosine 1-phosphate (S1P) receptor modulator, for treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). It is the third oral S1P receptor modulator to be approved in the US for treatment of relapsing forms of MS; siponimod (Mayzent) is also indicated for use in adults, and fingolimod (Gilenya) is approved for use in patients ≥10 years old.

The FDA has approved the injectable interleukin (IL)-17A/17F antagonist bimekizumab-bkzx (Bimzelx – UCB) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy. Bimekizumab is the first IL-17A/17F antagonist to be approved in the US. It was approved in the European Union for the same indication in 2021.

Since the introduction of fluoxetine (Prozac - Medical Letter, 30:45, 1988), bupropion (Wellbutrin - Medical Letter, 31:97, 1989), sertraline (Zoloft - Medical Letter, 34:47, 1992) and paroxetine (Paxil - this issue), the choice of an antidepressant has become more difficult. Should these widely prescribed new drugs replace tricyclic antidepressants such as amitriptyline (Elavil, and others), imipramine (Tofranil, and others), or nortriptyline (Aventyl, and others) for treatment of most patients with depression?