Nilotinib (Tasigna - Novartis), a tyrosine kinase inhibitor, has been approved by the FDA for treatment of Philadelphia chromosome-positive (Ph+) chronic or accelerated phase chronic myelogenous leukemia (CML) in patients resistant to or intolerant of imatinib (Gleevec).

The FDA has approved naloxegol (Movantik – AstraZeneca), a pegylated derivative of the opioid antagonist naloxone, for oral treatment of opioid-induced constipation in adults with chronic noncancer pain. It is the only oral opioid antagonist approved for this indication in the US.

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.

The FDA has approved zavegepant nasal spray (Zavzpret – Pfizer) for acute treatment of migraine with or without aura in adults. Zavzpret is the first nasal spray formulation of a calcitonin gene-related peptide (CGRP) receptor antagonist ("gepant") to become available in the US.

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 thiazolidinediones rosiglitazone (Avandia) and pioglitazone (Actos) are peripheral insulin sensitizing agents used to treat hyperglycemia in patients with type 2 diabetes; one or the other is often used as a second or third agent with metformin (Glucophage, and others) and/or a sulfonylurea such as glimepiride (Amaryl, and others). A recent report suggested that rosiglitazone may increase the incidence of myocardial infarction (MI) and cardiovascular mortality.

A new fixed-dose tablet (PrandiMet - Novo Nordisk) combining metformin (Glucophage, and others) and repaglinide (Prandin) has been approved by the FDA for treatment of type 2 diabetes in patients already taking both metformin and repaglinide, or for patients not adequately controlled on either drug alone.

An oral formulation of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Rybelsus – Novo Nordisk) has been approved by the FDA for once-daily treatment of type 2 diabetes in adults. Semaglutide, which has been available in a subcutaneously-injected formulation (Ozempic) since 2017, is the first GLP-1 receptor agonist to become available for oral administration; the 4 other GLP-1 receptor agonists currently available in the US are administered by subcutaneous (SC) injection.

The FDA has approved the marketing of another extended-release brand-name formulation of the serotonin and norepinephrine reuptake inhibitor (SNRI) desvenlafaxine (Khedezla – Par/Osmotica) for treatment of depression. It is the third extended-release formulation of desvenlafaxine to become available in the US. Khedezla was approved using a 505(b)(2) application, a new drug application (NDA) that relies upon the FDA's findings of safety and/or effectiveness for a previously approved drug.Khedezla does not appear to offer any advantage over the other extended-release formulations of...

The FDA is requiring a new warning in the prescription and over-the-counter labels of the oral second-generation H₁-antihistamines cetirizine (Zyrtec, and others) and levocetirizine (Xyzal, and others) about the risk of severe pruritus following discontinuation of treatment.