The FDA has approved Enstilar (Leo), an aerosol foam formulation of the synthetic vitamin D₃ analog calcipotriene and the high-potency corticosteroid betamethasone dipropionate, for topical treatment of plaque psoriasis in adults. Topical ointment and suspension formulations of the same combination have been available for many years.

The FDA has approved a 5% ophthalmic solution of lifitegrast (Xiidra – Shire), a lymphocyte function-associated antigen-1 (LFA-1) antagonist, for treatment of the signs and symptoms of dry eye disease. Lifitegrast is the first LFA-1 antagonist to be approved for any indication in the US.

The FDA has approved plecanatide (Trulance – Synergy), a guanylate cyclase-C receptor agonist, for treatment of chronic idiopathic constipation (CIC) in adults. Linaclotide (Linzess), another guanylate cyclase-C receptor agonist, and lubiprostone (Amitiza), a chloride channel activator, were approved earlier for treatment of CIC in adults.

The FDA has approved Vowst (Seres Therapeutics/Nestle HealthScience), an oral capsule containing live fecal microbiota spores, for prevention of additional recurrences of Clostridioides difficile infection (CDI) in adults. Vowst is the first orally administered microbiota-based treatment to be approved for this indication. A rectally-administered live fecal microbiota-based suspension (Rebyota) was approved in 2022 for the same indication. Neither product is approved for acute treatment of CDI.

The FDA has approved an epinephrine nasal spray (neffy – ARS Pharma) for emergency treatment of type 1 hypersensitivity reactions including anaphylaxis in patients who weigh ≥30 kg. It is the first noninjectable epinephrine product to be approved for this indication.

Many patients ask physicians to help them stop smoking. Since nicotine gum and patches were first marketed (Medical Letter, 26:47, 1984; 34:37, 1992), more data have become available on their effective use, and new formulations of the drug have been developed. Because of its slower rate of absorption, nicotine from gum or patches does not produce the pleasure some people associate with cigarette smoking, but it can relieve the irritability, difficulty in concentrating and other symptoms that occur after withdrawal from smoking.

Abarelix (Plenaxis - Praecis Pharmaceuticals), an injectable gonadotropin-releasing hormone (GnRH) antagonist, has been approved by the FDA for treatment of advanced symptomatic prostate cancer in patients who should not take luteinizing hormone-releasing hormone (LHRH) agonists and who refuse treatment with surgical castration.

Many physicians believe that antimicrobial prophylaxis before procedures that may cause transient bacteremia can prevent endocarditis and prosthetic joint infection in patients at increased risk for these disorders. The effectiveness of this common practice has never been established by controlled trials in humans.

Ferumoxytol (Fer yoo mox’ i tole; Feraheme – AMAG), an intravenous (IV) iron replacement product, has been approved by the FDA for treatment of iron deficiency anemia in adults with chronic kidney disease. Iron deficiency anemia is common in chronic kidney disease and may be associated with decreased absorption from the gastrointestinal tract, limiting the usefulness of oral iron replacement. IV iron replacement can lower the dose requirement for erythropoiesis-stimulating drugs, particularly in patients on dialysis

The FDA has approved plerixafor (Mozobil – Genzyme), a CXCR4 chemokine receptor antagonist, for use in combination with granulocyte-colony stimulating factor (G-CSF; Neupogen) to mobilize peripheral blood stem cells in adults with multiple myeloma or non-Hodgkin’s lymphoma before high-dose chemotherapy with autologous stem cell rescue.