Berotralstat (Orladeyo – Biocryst), an oral plasma kallikrein inhibitor, has been approved by the FDA for prevention of hereditary angioedema (HAE) attacks in adults and children ≥12 years old. The subcutaneously-injected plasma kallikrein inhibitor lanadelumab-flyo (Takhzyro) and the human plasma-derived C1 esterase inhibitors (C1INHs) Cinryze, which is given IV, and Haegarda, which is given SC, have been available for prophylaxis of HAE for years.

Liraglutide (Victoza – Novo Nordisk), a glucagon-like peptide-1 (GLP-1) receptor agonist given by subcutaneous injection, has been approved by the FDA for treatment of patients with type 2 diabetes. It can be used alone or in addition to oral antidiabetic drugs such as metformin (Glucophage, and others) or glimepiride (Amaryl, and others). Liraglutide is not recommended for first-line therapy and is not approved for use with insulin.

Fluconazole (Diflucan - Roerig), an antifungal azole, was recently approved by the US Food and Drug Administration for oral and intravenous (IV) treatment of cryptococcal meningitis and various forms of candidiasis. Both cryptococcal meningitis and candidiasis occur frequently in patients with AIDS, organ transplants, or cancer.

Ketorolac (kee'; toe role ak) tromethamine (Toradol), manufactured by Syntex but also marketed by Roche, is the first parenteral nonsteroidal anti-inflammatory drug (NSAID) to become available for analgesic use in the USA. Parenteral indomethacin (Indocin I.V.) has been marketed here since 1985, but only for treatment of patent ductus arteriosus in newborn infants. Other parenteral NSAIDs are available in other parts of the world, but low potency, poor aqueous solubility, and substantial tissue irritation on injection have limited their usefulness. Ketorolac has been approved by the US ...

The Immunization Practices Advisory Committee of the US Public Health Service now recommends immunizing all infants and some adolescents against hepatitis B and using a new diphtheria-tetanus-acellular pertussis vaccine (DTaP; ACEL-IMUNE - Lederle) for the fourth and fifth doses of DTP, usually given at 15 to 18 months of age and before school entry (Morbid Mortal Weekly Rep, 40 RR-13:1, November 22, 1991; Morbid Mortal Weekly Rep, 41 RR-1:1, Feb 7, 1992). The Committee on Infectious Diseases of the American Academy of Pediatrics has made similar recommendations but would extend...

Teriparatide (ter i par' a tide; Forteo - Lilly), a recombinant segment of human parathyroid hormone, has been approved by the FDA for parenteral treatment of osteoporosis in post-menopausal women, and in men with idiopathic or hypogonadal osteoporosis, who are at high risk for fracture. Teriparatide is the first approved treatment for osteoporosis that stimulates bone formation. Other drugs approved for this indication inhibit bone resorption (Treatment Guidelines from the Medical Letter 2002;1:13).

Adalimumab (Humira - Abbott), a tumor necrosis factor alpha (TNF-α) inhibitor, has been approved by the FDA for treatment of moderate to severe rheumatoid arthritis (RA). A genetically engineered human IgG1 monoclonal antibody, adalimumab is approved for subcutaneous (SC) injection in adults who have failed at least one disease-modifying anti-rheumatic drug (DMARD), for use either alone or with other DMARDs such as methotrexate (Rheumatrex, and others). Two other TNF-α antagonists, etanercept (Enbrel) and infliximab (Remicade), are already on the market for treatment of RA (Treatment...

Imiquimod cream 5% (Aldara - 3M), an immune modifier previously approved for treatment of genital and perianal warts (Medical Letter 1997; 39:118), has now been approved by the FDA for treatment of actinic keratoses (AKs) on the face or scalp, and may also be approved soon for treatment of basal cell carcinoma. It produces apoptosis in malignant, but not normal, human keratinocytes (M Sch÷n et al, J Natl Cancer Inst 2003; 95:1138).

Apomorphine (Apokyn - Mylan/Bertek), an injected non-ergot dopamine agonist, was recently approved by the FDA for intermittent subcutaneous (SC) treatment of hypomobility ("off" episodes) in patients with advanced Parkinson's disease. It has been available in Europe for many years.

Implanon (Organon), an implantable contraceptive containing the progestin etonogestrel, has been approved by the FDA. Two other implantable contraceptives, Norplant and Jadelle, which both contain levonorgestrel, are FDA-approved but not marketed in the US.