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The FDA has approved insulin degludec (Tresiba – Novo Nordisk) for treatment of adults with type 1 or type 2 diabetes. Insulin degludec is the third long-acting human insulin analog to be approved by the FDA; insulin detemir (Levemir) and insulin glargine (Lantus, Toujeo) were approved earlier.

The FDA has approved ceftolozane/tazobactam (Zerbaxa – Cubist), a combination of a new cephalosporin antibiotic and a beta-lactamase inhibitor, for intravenous treatment of complicated urinary tract and intra-abdominal infections in adults.

The FDA has approved Vuity (Abbvie), a 1.25% ophthalmic solution of the muscarinic receptor agonist pilocarpine hydrochloride, for treatment of presbyopia in adults. Pilocarpine 1%, 2%, and 4% ophthalmic solutions (Isopto Carpine, and others) have been available for years for treatment of glaucoma, but local and systemic adverse effects have limited their use.

The FDA has amended its Emergency Use Authorizations (EUAs) for the bivalent mRNA COVID-19 vaccines (original and Omicron BA.4/5 strains) manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit their use for all doses administered to persons ≥6 months old. The monovalent Pfizer and Moderna vaccines are no longer authorized for use in the US

Mirabegron (mir a beg’ ron; Myrbetriq [meer BEH trick] – Astellas), a beta-3 adrenergic agonist, has been approved by the FDA for the treatment of overactive bladder. It is the first beta-3 adrenergic agonist to be approved for any indication in the US. Mirabegron has been marketed in Japan since 2011. OnabotulinumtoxinA (Botox) was also recently approved by the FDA for treatment of overactive bladder and will be reviewed in a future issue.

The FDA has approved Winlevi (Sun), a 1% cream formulation of the androgen receptor inhibitor clascoterone, for treatment of acne vulgaris in patients ≥12 years old. It is the first topical androgen receptor inhibitor to be approved by the FDA.

The FDA has approved Epclusa (Gilead), a fixed-dose combination of sofosbuvir (Sovaldi) and velpatasvir, a new direct-acting antiviral agent, for oral treatment of chronic hepatitis C virus (HCV) infection. Epclusa is the first oral combination to be approved for treatment of all six major HCV genotypes.

The FDA has approved tirzepatide (Mounjaro – Lilly), a peptide hormone with activity at both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, to improve glycemic control in adults with type 2 diabetes. Tirzepatide, which is injected subcutaneously once weekly, is the first dual GIP/GLP-1 receptor agonist to become available in the US. Selective GIP receptor agonists are not available in the US; GLP-1 receptor agonists have been available for years.

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.