Fitusiran (Qfitlia – Sanofi), a subcutaneously injected, antithrombin-directed, small interfering ribonucleic acid (siRNA), has been approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients ≥12 years old who have hemophilia A with or without factor VIII inhibitors or hemophilia B with or without factor IX inhibitors. It is the first antithrombin-lowering therapy to become available in the US for treatment of hemophilia.

The FDA has approved bremelanotide (Vyleesi – Amag), a melanocortin receptor agonist, for subcutaneous treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). Bremelanotide is not approved for use in men or postmenopausal women. It is the second drug to be approved in the US for this indication; flibanserin (Addyi), which was approved in 2015, was the first.

Doripenem (Doribax - Ortho-McNeil Janssen), an intravenous (IV) carbapenem antibiotic with a spectrum of activity similar to that of imipenem and meropenem, has been approved by the FDA for treatment of complicated intra-abdominal and urinary tract infections. Use of doripenem for treatment of nosocomial pneumonia, including ventilator-associated pneumonia, is still under FDA review.

Excessive exposure to ultraviolet (UV) radiation can cause erythema, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but questions remain about their effectiveness and safety. In 2021, the FDA proposed a rule that would require additional safety studies for some sunscreen active ingredients and mandate better UVA protection in sunscreen products.

Voclosporin (Lupkynis – Aurinia), an oral calcineurin inhibitor, has been approved by the FDA for use in combination with the antimetabolite immunosuppressant mycophenolate mofetil (Cellcept, and generics) and a corticosteroid for treatment of adults with active lupus nephritis. It is the first calcineurin inhibitor to be approved in the US for this indication. Tacrolimus (Prograf, and others) and cyclosporine (Neoral, and others), the other available systemic calcineurin inhibitors, are approved for prophylaxis of organ rejection in transplant patients.

The FDA has approved the interleukin (IL)-23 antagonist mirikizumab-mrkz (Omvoh – Lilly) for treatment of moderately to severely active ulcerative colitis (UC) in adults. Mirikizumab is the first selective IL-23 antagonist to be approved for this indication. Ustekinumab (Stelara), an IL-12/23 antagonist, was approved for treatment of UC in 2019. The IL-23 antagonist risankizumab (Skyrizi) is approved for treatment of Crohn's disease.

The drugs of choice for treatment of fungal infections are listed in the table that begins on page 62. Some of the indications and dosages recommended here have not been approved by the FDA. More detailed guidelines for some of these infections are available online from the Infectious Diseases Society of America (www.idsociety.org).

Famciclovir (Famvir - SmithKline Beecham) is now available in the USA for oral treatment of acute uncomplicated herpes zoster (shingles). The manufacturer claims that use of the drug reduces the duration of postherpetic neuralgia. Famciclovir is similar to acyclovir (Zovirax - Burroughs Wellcome), which has been the drug of choice for treatment of varicella-zoster and herpes simplex virus infections (Medical Letter, 36:27, 1994).

Ceftibuten (Cedax - Schering), an oral cephalosporin similar to cefixime (Suprax - Medical Letter, 31:73, 1989), has been approved by the US Food and Drug Administration (FDA) for treatment of acute otitis media, pharyngitis or tonsillitis, and for acute bacterial exacerbations of chronic bronchitis.

Certolizumab pegol (Cimzia – UCB), a tumor necrosis factor (TNF) inhibitor previously approved for treatment of Crohn's disease and rheumatoid arthritis, and ustekinumab (Stelara – Janssen), a human interleukin-12 and -23 antagonist previously approved for treatment of moderate-to-severe plaque psoriasis, have now been approved by the FDA for treatment of active psoriatic arthritis.