The FDA has approved Lonsurf (Taiho Oncology), a combination of the thymidine-based nucleoside analog trifluridine and the thymidine phosphorylase inhibitor tipiracil, for oral treatment of metastatic colorectal cancer. Trifluridine is incorporated into DNA, interfering with DNA synthesis and inhibiting cell proliferation. Tipiracil inhibits the metabolism of trifluridine. The combination is only approved for use in patients who were previously treated with a fluoropyrimidine (fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF biological such as bevacizumab, and, if the tumor...

The FDA has approved adjunctive treatment with Dartisla ODT (Edenbridge), a new orally disintegrating tablet (ODT) formulation of the anticholinergic drug glycopyrrolate, to reduce symptoms of a peptic ulcer. Glycopyrrolate oral tablets (Robinul, Robinul Forte, and generics) were approved for the same indication in 1961.

The FDA is requiring a boxed warning in the label of denosumab (Prolia – Amgen), a monoclonal antibody that inhibits osteoclasts, about an increased risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD; eGFR <30 mL/min/1.73 m²), particularly those on dialysis. FDA-approved indications for Prolia are listed in Table 1.

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.