The FDA has warned that the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) are unlikely to neutralize the XBB.1.5 Omicron variant of SARS-CoV-2. Evusheld is available under an Emergency Use Authorization (EUA) for IM pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of a severe adverse reaction that prevents their vaccination against COVID-19 or moderate or severe immune compromise.

Finasteride and minoxidil continue to be the only drugs approved by the FDA to treat alopecia. Since these agents have different mechanisms of action, some clinicians have used both to treat hair loss in men.

Epiduo gel (Galderma), a fixed-dose combination of adapalene 0.1% (Differin), a synthetic retinoid analog, and benzoyl peroxide (BPO) 2.5%, an oxidizing agent, has been approved by the FDA for topical treatment of acne vulgaris in patients ≥12 years old.

The FDA has approved the use of ustekinumab (Stelara - Centocor Ortho Biotech), an interleukin antagonist given by subcutaneous (SC) injection for treatment of adults with moderate to severe plaque psoriasis. It is the first agent in its class for this indication; the other biologic agents for psoriasis are Tcell or tumor necrosis factor (TNF) inhibitors.

The FDA has approved a fixed-dose combination of the amide local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam as an extended-release (ER) solution (Zynrelef – Heron) for single-dose, intraoperative, soft-tissue or periarticular instillation to provide postsurgical analgesia for up to 72 hours in adults undergoing foot and ankle, small-to-medium open abdominal, or lower extremity total joint arthroplasty surgical procedures.

Concerns have surfaced again at the FDA and in the media about the safety of acetaminophen and the multiplicity of products on the market in the US that contain various amounts of it.

The FDA has approved delafloxacin (Baxdela – Melinta), an anionic fluoroquinolone antibiotic, for oral and parenteral treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant Staphylococcus aureus (MRSA). It is the first fluoroquinolone to be approved for treatment of MRSA.

Clopidogrel (Plavix - Sanofi-Aventis and Bristol-Myers Squibb), an oral thienopyridine that inhibits platelet aggregation, is now being advertised directly to the public on television. Clopidogrel is approved by the FDA for secondary prevention of myocardial infarction (MI), stroke and other vascular events and for use in patients with acute coronary syndrome (unstable angina or non-ST-elevation MI), including those undergoing angioplasty. It is used off-label for patients with ST-elevation acute MI

Several Medical Letter readers have asked about the meaning of non-inferiority trials. A non-inferiority trial is a comparison with an active control to determine whether the difference in response between the new drug and the active control is small enough (less than some pre-specified margin) to demonstrate that the new treatment is not less effective (or is only slightly less effective) than the control in achieving the primary outcome.1,2 Non-inferiority trials are appropriate when a proven effective treatment already exists and assigning some patients to a placebo group would be unethical...

Propofol (Diprivan - Stuart), a new intravenous (IV) sedative-hypnotic, was recently marketed in the USA for induction of anesthesia, or for maintenance of general anesthesia as part of a balanced anesthesia regimen. Older drugs used in a similar way include thiopental (Pentothal; and others) and midazolam (Versed).