Truvada (Gilead), an oral fixed-dose combination of the antiretrovirals emtricitabine and tenofovir disoproxil fumarate frequently used for treatment of HIV infection,1 has now also been approved by the FDA for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 in adults at high risk. It is the first drug to be approved for this indication. The CDC has been recommending Truvada off-label for pre-exposure prophylaxis in men who have sex with men since 2011.2 A 30-day supply of Truvada costs about $1160.3CLINICAL STUDIES — Approval for the new indication was based on 2...

Ibutilide fumarate (Corvert - Pharmacia & Upjohn), a new antiarrhythmic drug for intravenous use, has been approved by the US Food and Drug Administration for acute termination of atrial fibrillation or flutter of recent onset.

Sibutramine hydrochlorid monohydreate (Meridia - Knoll), which is structurally related to amphetamine, has been approved by the FDA for treatment of obesity. It is classified by the Drug Enforcement Agency (DEA) as a schedule IV controlled substance.

A recent article in JAMA and an interview of its senior author on 60 Minutes have heightened interest in off-label use of the oral selective serotonin reuptake inhibitor (SSRI) fluvoxamine (Luvox, and generics) to treat COVID-19.

The FDA has approved the interleukin-1 (IL-1) beta inhibitor canakinumab (Ilaris – Novartis) for treatment of systemic juvenile idiopathic arthritis (sJIA; formerly called juvenile rheumatoid arthritis or Still’s disease) in children ≥2 years old. Canakinumab was approved earlier for treatment of cryopyrin-associated periodic syndromes (CAPS). Tocilizumab (Actemra), an interleukin-6 (IL-6) inhibitor that has been available since 2010 for treatment of rheumatoid arthritis in adults, was also recently approved by the FDA for sJIA. Canakinumab is the only IL-1 inhibitor approved...

The FDA has approved eluxadoline (Viberzi – Actavis), a mu-opioid receptor agonist and delta-opioid receptor antagonist, for oral treatment of adults with irritable bowel syndrome with diarrhea (IBS-D).

The FDA has approved remibrutinib (Rhapsido – Novartis), an oral Bruton's tyrosine kinase (BTK) inhibitor, for treatment of chronic spontaneous urticaria in adults who remain symptomatic despite H₁-antihistamine treatment. Remibrutinib is the first oral drug to be approved in the US for this indication.

The FDA has approved bremelanotide (Vyleesi – Amag), a melanocortin receptor agonist, for subcutaneous treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). Bremelanotide is not approved for use in men or postmenopausal women. It is the second drug to be approved in the US for this indication; flibanserin (Addyi), which was approved in 2015, was the first.

The FDA has approved osilodrostat (Isturisa – Recordati), a cortisol synthesis inhibitor, for oral treatment of adults with Cushing's disease when surgical resection of the pituitary adenoma is not an option or has not been curative. Osilodrostat is the first cortisol synthesis inhibitor to be approved in the US for this indication. Other oral steroidogenesis inhibitors such as ketoconazole and metyrapone have been used off-label for this indication for many years.

Olsalazine sodium (Dipentum - Pharmacia), a dimer (two molecules linked by an azo bond) of 5-aminosalicylic acid, was recently approved by the US Food and Drug Administration for oral use to maintain remission of ulcerative colitis in adult patients who cannot tolerate sulfasalazine (Azulfidine; and others).