Almotriptan (Axert - Pharmacia), and Frovatriptan (Frova - Elan) have been approved by the FDA for oral treatment of migraine headache (Drugs of Choice from The Medical Letter 2001, page 131.).

The FDA has approved oral and injectable formulations of the HIV-1 capsid inhibitor lenacapavir (Sunlenca – Gilead) for use with other antiretroviral drugs to treat multidrug-resistant HIV-1 infection (MDR-HIV) in heavily treatment-experienced adults whose current regimen is failing. Lenacapavir is the third drug to be approved exclusively for treatment of MDR-HIV; the intravenously administered CD4-directed antibody ibalizumab-uiyk (Trogarzo) and the orally administered HIV-1 gp120-directed attachment inhibitor fostemsavir (Rukobia) were approved earlier.

The FDA has approved Symbravo (Axsome), an oral fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam and the 5-HT_1B/1D receptor agonist (triptan) rizatriptan (Maxalt, and generics), for acute treatment of migraine with or without aura in adults. It is the second combination of an NSAID and a triptan to be approved for migraine treatment. An oral fixed-dose combination of sumatriptan and naproxen (Treximet, and generics) is approved for use in patients ≥12 years old.

The FDA has approved Odactra (ALK), a sublingual allergen extract, for immunotherapy in adults 18-65 years old with house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis. Odactra is the first sublingual allergen extract to be approved in the US for this indication. Three other sublingual allergen extracts were approved earlier (see Table 1).

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.

Voriconazole (Vfend -- Pfizer), an antifungal triazole structurally related to fluconazole (Diflucan) with a spectrum of action similar to that of itraconazole, has been approved by the FDA for primary treatment of invasive aspergillosis and for refractory infection with Scedosporium apiospermum (the asexual form of Pseudallescheria boydii) or Fusarium spp.

Atazanavir (Reyataz - Bristol-Myers Squibb), a new protease inhibitor (PI), and emtricitabine (Emtriva - Gilead), a nucleoside analogue reverse transcriptase inhibitor (NRTI) chemically similar to lamivudine, have been approved by the FDA for treatment of HIV-1 infection. Both are taken once daily, unlike most anti-HIV drugs.

Posaconazole (Noxafil - Schering-Plough), an oral azole antifungal with a chemical structure similar to that of itraconazole (Sporanox), has been approved by the FDA to prevent Candida and Aspergillus infections in severely immunocompromised patients and for treatment of oropharyngeal candidiasis. It is likely also to be used off-label for treatment of other fungal infections, including those caused by Mucor and other Zygomycetes.

The FDA has approved Viekira Pak (Abbvie), a fixed-dose combination of two new direct-acting antiviral agents (ombitasvir, paritaprevir) with the pharmacologic enhancer ritonavir in one tablet, co-packaged with a third new direct-acting antiviral agent (dasabuvir) in a second tablet, for oral treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Genotype 1 is responsible for 70-80% of HCV infections in the US.

The FDA has approved vonoprazan, a potassium-competitive acid blocker, copackaged with amoxicillin (Voquezna Dual Pak – Phathom) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection in adults. Vonoprazan is the first potassium-competitive acid blocker to be approved in the US. It has been available in Japan for treatment of various acid-related disorders since 2014. Vonoprazan is not available alone in the US.