The FDA has approved fidaxomicin (Dificid – Optimer), a new oral macrolide antibiotic, for treatment of Clostridium difficile-associated diarrhea in patients ≥18 years old. The incidence and severity of C. difficile infection (CDI) have increased in recent years with the emergence of an epidemic hypervirulent strain (NAP1/B1/027), possibly related to widespread use of fluoroquinolones.

The FDA has approved talimogene laherparepvec (Imlygic – Amgen), a genetically modified herpes simplex virus, for intralesional treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma that has recurred following surgery. It is the first oncolytic virotherapy to become available in the US.

The FDA has approved Tarpeyo (Calliditas), a delayed-release capsule formulation of the corticosteroid budesonide, to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN; also called Berger's disease) who are at risk of rapid disease progression. It is the fi rst drug to be approved in the US for this indication. Oral formulations of budesonide have been available for years for treatment of inflammatory bowel disease.

The FDA has approved a 0.25% ophthalmic solution of the ectoparasiticide lotilaner (Xdemvy – Tarsus) for treatment of Demodex blepharitis. Lotilaner is the first drug to be approved in the US for this indication.

Avmapki Fakzynja Co-Pack (Verastem), a combination of the kinase inhibitors avutometinib and defactinib, has received accelerated approval from the FDA for treatment of KRAS-mutated recurrent low-grade serous ovarian cancer in women who had previously received systemic therapy. Neither drug is approved for use as monotherapy for any indication. Avmapki Fakzynja is the first treatment to be approved in the US for this indication.

Since the last Medical Letter review of cephalosporin antibiotics (volume 25, page 57, 1983), many new cephalosporins have become available in the USA.

The recent terrorist attacks on the US have led to many questions about the clinical effects, prevention and treatment of injury caused by chemical warfare agents.

The FDA has approved Clenpiq (Ferring), a low-volume oral solution that contains sodium picosulfate, magnesium oxide, and anhydrous citric acid, for colon cleansing prior to colonoscopy in adults. The ready-to-drink solution contains the same ingredients as Prepopik, which is supplied as a powder for reconstitution.

This article includes recommendations for management of most sexually transmitted infections (STIs) other than HIV and viral hepatitis. Some of the indications and dosages recommended here have not been approved by the FDA (see Table 1).

Terconazole (Terazol - Ortho), an imidazole derivative, was recently marketed in the USA for treatment of vulvovaginal candidiasis. It is available both as a 0.4% vaginal cream (Terazol 7) and in 80-mg vaginal suppositories (Terazol 3).