Loracarbef (Lorabid - Lilly), a new beta-lactam antibiotic with antimicrobial activity similar to the second-generation cephalosporins, has been approved by the US Food and Drug Administration for treatment of respiratory, skin, and urinary tract infection caused by susceptible organisms in both adults and children. It will probably compete with drugs such as trimethoprim-sulfamethoxazole (Bactrim, Septra, and others), amoxicillin-clavulanic acid (Augmentin), cefaclor (Ceclor), cefuroxime axetil (Ceftin), and cefprozil (Cefzil - Medical Letter, 34:63,...

Rimantadine hydrochloride (Flumadine - Forest), the alpha-methyl derivative of amantadine (Symmetrel, and others), was recently approved by the US Food and Drug Administration for prevention and treatment of influenza A virus infections in adults and for prevention of influenza in children.

The heptavalent pneumococcal conjugate vaccine (Prevnar - Wyeth) previously approved by the FDA for prevention of invasive pneumococcal disease in infants and children (Medical Letter 2000; 42:25) has now also been approved for prevention of otitis media. Infants and young children have higher antibody responses to the heptavalent conjugate vaccine (PCV7) than to the older 23-valent pneumococcal polysaccharide vaccine (PPV23) used in adults and older children (D Murray and C Jackson, Mil Med 2002; 167:671).

Butenafine hydrochloride 1% cream (Mentax - Penederm), a benzylamine antifungal drug similar to the allylamines terbinafine (Lamisil) and naftifine (Naftin), is now available in the USA for topical treatment of tinea pedis, tinea corporis and tinea cruris.

The Bruton's tyrosine kinase (BTK) inhibitor pirtobrutinib (Jaypirca – Lilly) has received accelerated approval from the FDA for treatment of relapsed or refractory mantle cell lymphoma (MCL) in adults who received ≥2 prior lines of systemic therapy, including a BTK inhibitor. Accelerated approval was based on the response rate. The BTK inhibitors ibrutinib (Imbruvica), acalabrutinib (Calquence), and zanubrutinib (Brukinsa) are also approved for treatment of MCL.

A reader of our article on the 2024-2025 formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) asked us to provide more information on the data that supported their licensure.

Increased resistance of pneumococci to antimicrobial drugs may encourage more extensive use of pneumococcal polysaccharide vaccine.

No vaccines against tickborne encephalitis (TBE) or dengue are available in the US, but vaccines have been licensed in some other countries.

Annual vaccination against influenza A and B viruses is recommended in the US for everyone ≥6 months old without a contraindication. Influenza vaccines available in the US for the 2025-2026 season are listed in Table 2.

On September 22, on the advice of its Vaccines and Related Biologic Products Advisory Committee, the FDA expanded the Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine (Comirnaty) to include administration of a booster dose ≥6 months after a 2-dose primary series in adults who are ≥65 years old or at high risk for severe COVID-19 because of an underlying medical condition or frequent institutional or occupational exposure to SARS-CoV-2 (see Table 1). The FDA Advisory Committee recommended against authorization of a booster dose of Comirnaty...