The FDA has approved rifamycin (Aemcolo – Cosmo/ Aries), a minimally absorbed oral antibiotic, for treatment of adults with travelers' diarrhea (TD) caused by noninvasive strains of Escherichia coli. It is not recommended for treatment of diarrhea that is complicated by fever and/or bloody stools. Topical and injectable formulations of rifamycin have been used in Europe for other indications for many years.

The FDA has approved a sublingual tablet (Nocdurna – Ferring) and a nasal spray (Noctiva – Avadel) formulation of desmopressin acetate for treatment of nocturia due to nocturnal polyuria in adults who wake up ≥2 times per night to void. Nocdurna and Noctiva are the first two products to be approved in the US for this indication. Higher-strength nasal spray and oral tablet formulations of desmopressin (DDAVP, and others) have been available for years for treatment of diabetes insipidus and primary nocturnal enuresis (bedwetting in children). In 2007, the indication for primary...

The FDA has approved siponimod (Mayzent – Novartis), a sphingosine 1-phosphate (S1P) receptor modulator, for oral 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). Siponimod is the second S1P receptor modulator to be approved in the US; fingolimod (Gilenya), which is approved for oral treatment of relapsing forms of MS in patients ≥10 years old, was the first. The purine antimetabolite cladribine (Mavenclad) was also...

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 solriamfetol (Sunosi – Jazz), a dopamine and norepinephrine reuptake inhibitor (DNRI), to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA). Pitolisant (Wakix), an H3-receptor antagonist/inverse agonist recently approved by the FDA for treatment of excessive daytime sleepiness in patients with narcolepsy, will be reviewed in a future issue.

The FDA has approved Dovato (ViiV), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay) and the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (Epivir, and generics), as a once-daily complete regimen for treatment of adults with HIV-1 infection who are antiretroviral-treatment naive and have no known substitutions associated with resistance to either drug. Dolutegravir/lamivudine is the first complete regimen to be approved by the FDA for initial treatment of HIV-1 infection that contains 2 rather than 3 antiretroviral...

The FDA has approved trifarotene 0.005% cream (Aklief – Galderma) for topical treatment of acne vulgaris in patients ≥9 years old. Trifarotene is the fourth topical retinoid to be approved in the US for treatment of acne; tretinoin (Retin-A, and others), adapalene (Differin, and generics), and tazarotene (Tazorac, and others) have been available by prescription for decades. Adapalene 0.1% gel has been available over the counter since 2016 for treatment of acne in patients ≥12 years old.

The FDA has approved letermovir (Prevymis – Merck), a cytomegalovirus (CMV) DNA terminase complex inhibitor, for prophylaxis of CMV infection and disease in CMV-seropositive adult recipients of an allogeneic hematopoietic cell transplant (HCT). Letermovir is the first CMV DNA terminase complex inhibitor to be approved in the US and the only drug specifically indicated for CMV prophylaxis in HCT patients. It is not approved for treatment of CMV infection.

The FDA has approved two new drugs for sickle cell disease: crizanlizumab-tmca (Adakveo – Novartis), an IV P-selectin blocker, and voxelotor (Oxbryta – GBT), an oral hemoglobin S (HbS) polymerization inhibitor.

The FDA has approved a fixed-dose combination of omeprazole, amoxicillin, and rifabutin (Talicia – RedHill) for treatment of Helicobacter pylori infection in adults. Talicia is the first rifabutin-based product to be approved for this indication.