Atogepant (Qulipta – Abbvie), an oral small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist ("gepant"), has been approved by the FDA for prevention of episodic migraine in adults. It is the second oral CGRP receptor antagonist to be approved in the US for this indication; the first was rimegepant (Nurtec ODT), which is also approved for acute treatment of migraine. Parenteral CGRP monoclonal antibodies are approved for prevention of migraine (see Table 3).

Faricimab-svoa (Vabysmo – Genentech), an inhibitor of both vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), has been approved by the FDA for intravitreal treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). It is the first drug to become available in the US that targets two pathways involved in maintaining vascular homeostasis. Several VEGF inhibitors are available for treatment of nAMD and DME (see Table 2).

A 0.75% vaginal gel formulation of metronidazole (MetroGel-Vaginal - Curatek) and a 2% vaginal cream formulation of clindamycin phosphate (Cleocin - Upjohn) were recently approved by the US Food and Drug Administration for treatment of bacterial vaginosis. Seven days' treatment with oral metronidazole, 500 mg b.i.d., has been the usual treatment for this condition, with oral clindamycin, 300 mg b.i.d., as an alternative (JL Thomason et al, Am J Obstet Gynecol, 165:1210, 1991).

Ibutilide fumarate (Corvert - Pharmacia & Upjohn), a new antiarrhythmic drug for intravenous use, has been approved by the US Food and Drug Administration for acute termination of atrial fibrillation or flutter of recent onset.

Azelaic acid, a naturally occurring heptanedicarboxylic acid, has been marketed in the USA as a 20% cream (Azelex - Allergan) for treatment of acne. The drug has been available in Europe for several years.

Dolasetron (Anzemet - Hoechst Marion Roussel), a selective serotonin (5-HT3) receptor antagonist similar to ondansetron (Zofran) and granisetron (Kytril - Medical Letter, 36:61, 1994) is now available for both oral and intravenous use in prevention of nausea and vomiting due to cancer chemotherapy. A 5-HT3 antagonist plus dexamethasone (Decadron, and others) is the most effective regimen for prevention of acute vomiting caused by cancer chemotherapy. Dolasetron has also been approved by the FDA for prevention and treatment of postoperative nausea and...

Adjuvant hormone therapy with anti-estrogen drugs has been shown to reduce disease recurrence and mortality in postmenopausal women with estrogen receptor (ER)-positive breast cancer. In recent years, aromatase inhibitors (AI) have become the preferred first-line hormonal treatment over tamoxifen for such patients.1,2

A recent article in JAMA and an interview of its senior author on 60 Minutes have heightened interest in off-label use of the oral selective serotonin reuptake inhibitor (SSRI) fluvoxamine (Luvox, and generics) to treat COVID-19.

The FDA has approved RiVive (Harm Reduction Therapeutics), a 3-mg naloxone nasal spray, as an over-the-counter (OTC) product for emergency treatment of opioid overdose. Two 4-mg naloxone nasal spray formulations, Narcan and one of its generics, were approved for OTC sale in 2023.

The FDA has approved Erzofri (Luye), an extended-release injectable formulation of the second-generation antipsychotic drug paliperidone palmitate, for treatment of schizophrenia and schizoaffective disorder in adults. It is the second once-monthly formulation of paliperidone palmitate to be approved in the US for these indications; Invega Sustenna was the first. Longer-acting injectable formulations of paliperidone palmitate are also available (see Table 1).