Two cholesterol-lowering margarines have been marketed in the USA.

The FDA has approved a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) elvitegravir, the pharmacokinetic enhancer cobicistat, and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir disoproxil fumarate (Stribild – Gilead) for treatment of HIV-1 infection in antiretroviral treament-naïve adults. Elvitegravir is the second INSTI to be approved by the FDA for use in HIV treatment; raltegravir (Isentress) was the first.

Resmetirom (Rezdiffra – Madrigal), a thyroid hormone receptor-beta agonist, has received accelerated approval from the FDA for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced fibrosis in adults. NASH has recently been renamed metabolic dysfunction-associated steatohepatitis (MASH). Resmetirom is the first drug to be approved in the US for this indication.

Lopinavir/ritonavir is the first fixed-dose combination of protease inhibitors approved by the FDA for the treatment of HIV infection. It is being marketed for use with other drugs in adults and children more than six months old. Lopinavir is a new drug available only in this combination. Ritonavir is often used with other protease inhibitors to raise their plasma concentrations.

The FDA has approved ticagrelor (Brilinta – AstraZeneca), an oral antiplatelet drug, for use with low-dose aspirin to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS). It will compete with clopidogrel (Plavix) and prasugrel (Effient) for such use. Clopidogrel is expected to become available generically in the US within the next few months.

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...

The FDA has approved Mavyret (Abbvie) and Vosevi (Gilead), two new fixed-dose combinations of direct-acting antiviral (DAA) drugs, for treatment of chronic hepatitis C virus (HCV) infection caused by any of the six major HCV genotypes in patients without cirrhosis or with compensated cirrhosis. Both are approved for use in treatment-experienced patients. Mavyret is also approved for treatment-naive patients.

The FDA has approved the marketing of extended release (ER) ranolazine (Ranexa - CV Therapeutics) for treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs. It should be used in combination with a nitrate, a beta-blocker or the dihydropyridine calcium-channel blocker amlodipine (Norvasc), and appears to be more effective in men. The labeling for ranolazine specifies amlodipine as the calcium-channel blocker of choice because the use of other dihydropyridines with ranolazine has not been studied, and use with diltiazem (Cardizem, and...

The FDA has approved flibanserin (Addyi – Sprout) for treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) not caused by another medical or psychiatric condition, the effects of another drug, or relationship difficulties. Flibanserin is the first drug to be approved for treatment of HSDD. It is not approved for use in men or postmenopausal women. Previous FDA reviews of flibanserin in 2010 and 2013 did not result in approval.

The FDA has approved tocilizumab (Actemra – Genentech; RoActemra in Europe) for intravenous (IV) treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to tumor necrosis factor (TNF) inhibitors.