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).

The FDA has approved five tumor necrosis factor (TNF) inhibitors for treatment of moderately to severely active rheumatoid arthritis (RA). TNF-α is a pro-inflammatory cytokine involved in the pathogenesis of many systemic inflammatory disorders.

The FDA has approved romidepsin (Istodax – Celgene), an IV histone deacetylase (HDAC) inhibitor, for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. The most common types of CTCL are mycosis fungoides, a low-grade lymphoma usually confined to the skin, and Sézary syndrome, a more aggressive disease with malignant lymphocytes in the blood. Both can progress to fatal systemic involvement. Romidepsin is the second HDAC inhibitor approved for this indication; vorinostat (Zolinza), an oral HDAC inhibitor, was approved...

The FDA has approved onasemnogene abeparvovec-xioi (Zolgensma – Avexis), an adeno-associated virus vector-based gene therapy, for one-time IV treatment of children <2 years old who have spinal muscular atrophy (SMA) and bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. It is the first gene therapy and the second drug to be approved in the US for SMA; nusinersen (Spinraza) was approved in 2016.

View the Expanded Table: Some Drugs for Altitude Illness, Jet Lag, and Motion Sickness