Metformin (Glucophage, and others) is generally preferred as the first-line agent for treatment of type 2 diabetes, but most patients subsequently require treatment with more than one drug. Many combination products have been marketed; the latest of these combines saxagliptin with extended-release (ER) metformin as Kombiglyze XR.

The FDA has approved the nucleotide polymerase inhibitor sofosbuvir (Sovaldi – Gilead) for use in combination with other antiviral drugs for treatment of chronic hepatitis C virus (HCV) infection.

The FDA has issued an Emergency Use Authorization (EUA) for Lilly's investigational monoclonal antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) to be administered together for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease and/or hospitalization (see Table 1). Bamlanivimab received an EUA for use as monotherapy in such patients in November 2020. Regeneron's investigational monoclonal antibodies casirivimab (REGN10933) and imdevimab (REGN10987) are also authorized for use...

A combination tablet containing estradiol and drospirenone (Angeliq - Berlex) recently became available for treatment of moderate to severe menopausal symptoms in women with an intact uterus. Since the last Medical Letter issue reviewing such devices,1 more continuous glucose monitoring (CGM) systems have become available. Five devices available now, and two expected to be marketed soon, are listed in the table on page 14. The FDA has approved continuous glucose devices only for the observation of glucose trends.

The FDA has approved a two-dose hepatitis B virus (HBV) vaccine (Heplisav-B – Dynavax) for use in adults ≥18 years old. The three other HBV vaccines marketed in the US are usually administered in 3 doses. Engerix-B and Recombivax HB are licensed for use in persons of all ages. A combination hepatitis A/B vaccine (Twinrix) contains the same hepatitis B component as Engerix-B and is licensed for use only in adults.

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...

Since the last Medical Letter review of generic drugs (Volume 28, page 1, 1986), the prediction that generic drugs newly approved in the USA under more relaxed federal regulations will probably be as reliable as brand-name drugs has generally been accurate. Few well-documented generic product failures have been reported. Recently, however, the equivalence of generic topical corticosteroids has been questioned.

The FDA has approved an extended-release formulation of clonidine hydrochloride (Kapvay– Shionogi) for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-17 years old. It is the second alpha₂-adrenergic agonist approved for this indication; guanfacine hydrochloride (Intuniv) was the first, but only clonidine is approved for use with stimulants.

Terconazole (Terazol - Ortho), an imidazole derivative, was recently marketed in the USA for treatment of vulvovaginal candidiasis. It is available both as a 0.4% vaginal cream (Terazol 7) and in 80-mg vaginal suppositories (Terazol 3).

The Advisory Committee on Immunization Practices (ACIP) has issued new recommendations for meningococcal vaccination. Booster vaccination against Neisseria meningitidis serogroup B (MenB) is now recommended in persons at increased risk for meningococcal disease (see Table 1). MenB booster doses were not recommended previously for any population.