The FDA has approved vonoprazan (Voquezna – Phathom), a potassium-competitive acid blocker, for healing and maintenance of healing of all grades of erosive esophagitis and relief of associated heartburn in adults. Vonoprazan is also available copackaged with amoxicillin (Voquezna Dual Pak) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection in adults.

The FDA has approved an oral extended-release formulation of gepirone (Exxua – Fabre-Kramer), a selective 5-HT_1A receptor agonist, for treatment of major depressive disorder (MDD) in adults. Gepirone was originally developed decades ago for treatment of anxiety and depression, but it was not approved by the FDA for such use. Gepirone is structurally related to buspirone, which is FDA-approved for treatment of anxiety.

View the Comparison Table: Some Oral Antiseizure Medications

The FDA has removed the requirement that mifepristone (Mifeprex, and generics), a progestin receptor antagonist approved for use in a regimen with the prostaglandin E1 analog misoprostol (Cytotec, and generics) for medical termination of pregnancy, must be dispensed in person to the patient.

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.

Eflornithine (Iwilfin – US WorldMeds), an oral ornithine decarboxylase inhibitor, has been approved by the FDA to reduce the risk of relapse in children and with high-risk neuroblastoma who had at least a partial response to prior multiagent, multimodality therapy, including anti-GD2 immunotherapy. About 40-50% of neuroblastoma cases are classified as high-risk and they account for ~15% of all pediatric cancer deaths. Eflornithine is the first drug to be approved to reduce the risk of relapse in children with high-risk neuroblastoma. Eflornithine was previously available in the US...

View the Comparison Table: Some Parenteral Anticoagulants for VTE

The FDA has approved margetuximab-cmkb (Margenza – MacroGenics), a HER2/neu receptor antagonist, for use in combination with chemotherapy for treatment of metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who received ≥2 prior anti-HER2 regimens, at least one of which was for metastatic disease.

Adagrasib (Krazati – Mirati Therapeutics), a RAS GTPase family inhibitor, has received accelerated approval from the FDA for oral treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who received at least one prior systemic therapy. Accelerated approval was based on the objective response rate and duration of response.

Balfaxar (Octapharma), a human plasma-derived four-factor prothrombin complex concentrate (PCC), has been approved by the FDA for rapid reversal of warfarin anticoagulation in adults who require an urgent surgical/invasive procedure. It is the second four-factor PCC to become available in the US; Kcentra, which has been available since 2013, is approved for the same indication and for urgent reversal of warfarin anticoagulation in adults with acute major bleeding. Balfaxar is marketed in Canada and Europe as Octaplex.