The FDA has issued an Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to be administered concomitantly by IM injection for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of severe allergy that prevents their vaccination against COVID-19 or moderate or severe immune compromise (see Table 1). They are the first drugs to be authorized by the FDA for this indication. Two other pairs of antibodies, bamlanivimab plus etesevimab...

View the Comparison Chart: Correct Use of Inhalers for Asthma

Palopegteriparatide (Yorvipath – Ascendis), a parathyroid hormone (PTH) 1-34 analog, has been approved by the FDA for treatment of hypoparathyroidism in adults. The parathyroid hormone analog teriparatide (Forteo, and others), which is approved for treatment of postmenopausal osteoporosis, has been used off-label for treatment of hypoparathyroidism.

Dehydroepiandrosterone (DHEA), an endogenous adrenal steroid, is marketed as a dietary supplement in the US. It is widely promoted to reverse the effects of aging (loss of muscle, memory and libido) and has been used by athletes as a substitute for anabolic steroids. DHEA is banned by the International Olympic Committee, National Collegiate Athletic Association, National Football League and other sports organizations, but it was specifically exempted from becoming a controlled substance in the Anabolic Steroid Control Act of 2004.

Acupuncture is the practice of inserting fine needles for therapeutic purposes into points on the skin known as acupoints. In traditional Chinese medicine theory, these points arefound along channels that conduct "qi" (pronounced "chee"), or energy. In addition to insertion of needles, acupoints can be stimulated by heat, electrical current or just pressure.

Insulin detemir (Levemir - Novo Nordisk) is the second long-acting basal insulin analog to be marketed in the US for treatment of both type 1 and type 2 diabetes. Detemir differs from human insulin by the elimination of the amino acid threonine in position B30 and the addition of a 14-carbon fatty acid chain at position B29. Insulin glargine (Lantus), the first long-acting insulin analog, has been available since 2001 and is usually given once daily.1 NPH insulin is an intermediate-acting basal insulin given twice daily. Basal insulins are usually combined with prandial doses of a rapid-acting...

Golimumab (Simponi - Centocor), a fully humanized anti-tumor necrosis factor (TNF)-a antibody, has been approved by the FDA for the treatment of: (1) moderate to severe active rheumatoid arthritis (RA) in combination with methotrexate; (2) active psoriatic arthritis (PsA) alone or in combination with methotrexate; and (3) active ankylosing spondylitis (AS).

The FDA has approved ceftolozane/tazobactam (Zerbaxa – Cubist), a combination of a new cephalosporin antibiotic and a beta-lactamase inhibitor, for intravenous treatment of complicated urinary tract and intra-abdominal infections in adults.

The FDA has approved Toujeo (Sanofi), a more concentrated form of insulin glargine containing 300 IU/mL compared to the 100 IU/mL in Lantus (Sanofi). Lantus is nearing the end of its patent protection in the US, and biosimilars are expected to become available.

Epirubicin, an analog of doxorubicin that has been available in Europe and Canada for 15 years, has now been approved by the FDA for adjuvant use after resection of the primary tumor in breast cancer patients with axillary node involvement.