The FDA has approved pomalidomide (Pomalyst – Celgene), an oral thalidomide analog, for treatment of patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide (Revlimid) and bortezomib (Velcade) and whose disease had progressed on or within 60 days of completion of the last therapy.

A live attenuated varicella-zoster vaccine (Zostavax - Merck) has been approved by the FDA for prevention of herpes zoster (HZ; zoster; shingles) in persons ≥60 years old. Each dose of Zostavax contains about 14 times as much varicella-zoster virus (VZV) as Varivax, which has been used in the US since 1995 to vaccinate against varicella (chicken pox).

The FDA has approved ofatumumab (Arzerra – GlaxoSmithKline), a human anti-CD20 monoclonal antibody, for treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine (Fludara, and others) and alemtuzumab (Campath). It is the second anti-CD20 antibody approved for treatment of CLL; rituximab (Rituxan), a chimeric murine/human antibody, was the first.

The FDA has approved the marketing of Vimovo (AstraZeneca), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) naproxen and the proton pump inhibitor (PPI) esomeprazole, for symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk for NSAID-associated ulcers.

The FDA has approved a 5% ophthalmic solution of lifitegrast (Xiidra – Shire), a lymphocyte function-associated antigen-1 (LFA-1) antagonist, for treatment of the signs and symptoms of dry eye disease. Lifitegrast is the first LFA-1 antagonist to be approved for any indication in the US.

The FDA has approved cyclosporine 0.09% ophthalmic solution (Cequa – Sun) to increase tear production in patients with keratoconjunctivitis sicca (dry eye disease). Restasis, a 0.05% cyclosporine emulsion, was approved in the US in 2003 for the same indication.

Tirbanibulin, a microtubule inhibitor, has been approved by the FDA as a 1% ointment (Klisyri – Almirall) for topical treatment of actinic keratosis of the face or scalp.

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...

Many drugs can cause psychiatric symptoms, but a causal connection is often difficult to establish. Psychiatric symptoms that emerge during drug treatment could also be due to the underlying illness, previously unrecognized psychopathology, or psychosocial factors. The withdrawal of some drugs can cause symptoms such as anxiety, psychosis, delirium, agitation or depression.

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Itraconazole (Sporanox - Janssen), an antifungal triazole, has been approved by the US Food and Drug Administration (FDA) for oral treatment of histoplasmosis and blastomycosis. These two endemic mycoses occur both in normal hosts and in immunocompromised patients, such as those with AIDS (RW Bradsher, Clin Infect Dis, 14:S82, 1992; LJ Wheat, Clin Infect Dis, 14:S91, 1992).