Bexagliflozin (Brenzavvy – TheracosBio), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved by the FDA to improve glycemic control in adults with type 2 diabetes. It is the fifth SGLT2 inhibitor to be approved in the US for this indication (see Table 4).

Eszopiclone (Lunesta - Sepracor), a benzodiazepine-like drug, has been approved by the FDA for oral treatment of insomnia. It is the S-isomer of zopiclone (Imovane, and others in Canada), which has been available in other countries for almost 20 years. Unlike similar drugs such as zolpidem (Ambien) or zaleplon (Sonata), Lunesta is not being restricted in its labeling to short-term use. Like other hypnotics, eszopiclone is a schedule IV drug.

Ambrisentan (Letairis - Gilead), a selective endothelin type A (ET_A) receptor antagonist, has been approved by the FDA for treatment of symptomatic patients (WHO class II or III) with pulmonary arterial hypertension (PAH).

Raltegravir (Isentress - Merck), the first in a new class of oral HIV drugs called HIV-1 integrase strand transfer inhibitors (InSTI), has received accelerated FDA approval for use in combination therapy for treatment-experienced adults infected with HIV-1 strains resistant to multiple antiretroviral agents.

Maraviroc (Selzentry - Pfizer), the first CCR5 (CC chemokine receptor 5) antagonist has received the same FDA approval but is restricted to use in adults with CCR5-tropic HIV-1 ("R5 virus"). A commercial assay is available for R5 tropism.

The FDA has approved the marketing of pitavastatin (Livalo – Kowa), an HMG-CoA reductase inhibitor (“statin”), for treatment of primary hyperlipidemia or mixed dyslipidemia. It has been available in Japan since 2003. All of the statins now available in the US are listed in the table on page 58.

Artesunate for injection (Amivas LLC), a semi-synthetic artemisinin derivative, is now approved by the FDA for initial (induction) treatment of severe malaria in children and adults. It has been available from the CDC on a compassionate use basis since 2007. Artemether/lumefantrine (Coartem), another artemisinin-based drug, was approved earlier for oral treatment of uncomplicated Plasmodium falciparum malaria. IV artesunate is now the only FDA-approved injectable antimalarial drug available in the US; IV quinidine has been discontinued.

Many prescriptions for eye drops call for instillation of 1-2 drops. But Medical Letter consultants in ophthalmology seem to agree that all eye drops should generally be given in doses of only one drop. The volume of a single drop can vary with the viscosity of the solution, the design of the dropper, and patient technique. The average volume of a drop is 35-50 microliters, but can be as high as 75 microliters. An eye brimming with fluid holds 30 microliters at best, so even one drop is often an overdose. A second either washes out the first or increases the possibility of systemic toxicity,...

Fluticasone furoate nasal spray (Veramyst - GSK) is now available for once-daily treatment of seasonal and perennial allergic rhinitis in adults and children ≥2 years old. It is similar to fluticasone propionate nasal spray (Flonase, and others), which is now available generically.

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.

Primary hypothyroidism is usually the result of Hashimoto's thyroiditis, thyroidectomy for hyperthyroidism, goiter or cancer, or radioactive iodine therapy for hyperthyroidism.