The FDA has approved Trudhesa (Impel Neuropharma), a new dihydroergotamine nasal spray product, for acute treatment of migraine with or without aura in adults. Another dihydroergotamine nasal spray (Migranal, and generics) has been available for many years for the same indication.

The FDA has approved Combogesic IV (Hikma), an IV solution containing acetaminophen and ibuprofen, to treat mild to moderate pain (alone) or moderate to severe pain (in combination with an opioid) in adults when IV analgesia is considered clinically necessary. Single-drug IV solutions containing ibuprofen (Caldolor) and acetaminophen have been available in the US for years.

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 drugs of choice for treatment of fungal infections are listed in the table that begins on page 62. Some of the indications and dosages recommended here have not been approved by the FDA. More detailed guidelines for some of these infections are available online from the Infectious Diseases Society of America (www.idsociety.org).

Previously approved by the FDA for treatment of depression, general anxiety disorder, diabetic peripheral neuropathic pain and fibromyalgia, duloxetine (Cymbalta – Lilly) has now also been approved for treatment of chronic musculoskeletal pain.

The FDA has approved ivacaftor (eye va kaf’ tor; Kalydeco – Vertex) for oral treatment of cystic fibrosis (CF) in patients ≥6 years old with the G551D mutation, which is found in about 5% of patients with CF. It is the first drug approved in the US that treats the cause of the disease.

The FDA has approved vorasidenib (Voranigo – Servier), an oral isocitrate dehydrogenase (IDH) inhibitor, for treatment of grade 2 astrocytoma or oligodendroglioma in patients ≥12 years old with an IDH1 or IDH2 mutation. It is the first systemic treatment to be approved in the US for this indication.

Atovaquone (Mepron - Burroughs Wellcome), a hydroxynaphthoquinone, was recently approved by the US Food and Drug Administration (FDA) for oral treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in patients who cannot tolerate trimethoprim-sulfamethoxazole (Septra, Bactrim, and others). PCP is a common opportunistic infection and frequent cause of death in patients with AIDS.

The FDA has approved an IV formulation of the antifungal drug posaconazole (Noxafil - Merck) for prophylaxis of Aspergillus and Candida infections in adults at high risk for these infections, such as those with prolonged neutropenia. Posaconazole is also available as delayed-release tablets and an oral suspension.With activity against Aspergillus and Candida, posaconazole has an antifungal spectrum similar to that of voriconazole (Vfend, and generics), but unlike voriconazole it is also active against many species of Mucorales (formerly called Zygomycetes), such as Mucor and Rhizopus....

Vardenafil (Levitra -Bayer) is the second oral drug approved by the FDA for treatment of erectile dysfunction. Sildenafil (Viagra - Medical Letter 1998; 40:51), the first oral drug, has been available for 5 years. Pharmacokinetics, effectiveness, adverse effects, dosage and cost of the new drug are reviewed. Whether it offers any benefits over sildenafil is discussed.