The FDA has approved elvitegravir (Vitekta – Gilead), an integrase strand transfer inhibitor (INSTI), for use with a protease inhibitor (PI) plus ritonavir and other antiretroviral drugs for treatment of HIV-1 infection in treatment-experienced adults. Elvitegravir is also available in a fixed-dose combination (Stribild) with the pharmacokinetic enhancer cobicistat and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir disoproxil fumarate (DF). A similar combination (Genvoya) that includes tenofovir alafenamide instead of tenofovir...

The FDA has approved Duzallo (Ironwood), a fixed-dose combination of the uric acid transporter 1 (URAT1) inhibitor lesinurad (Zurampic) and the xanthine oxidase inhibitor allopurinol (Zyloprim, and generics), for once-daily treatment of gout-associated hyperuricemia in patients who have not achieved target serum uric acid levels with allopurinol alone.

The FDA has approved nasal spray formulations of the benzodiazepines diazepam (Valtoco — Neurelis) and midazolam (Nayzilam — UCB) for acute treatment of intermittent episodes of frequent seizure activity (seizure clusters). Diazepam rectal gel (Diastat, Diastat AcuDial, and generics) has been used for this indication for many years.

The FDA has approved sacituzumab govitecan-hziy (Trodelvy – Immunomedics), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with metastatic triple-negative breast cancer who have received ≥2 prior therapies for metastatic disease. It is the first Trop-2-directed antibody-drug conjugate to become available in the US.

The oral sphingosine 1-phosphate (S1P) receptor modulator etrasimod (Velsipity – Pfizer) has been approved by the FDA for treatment of moderately to severely active ulcerative colitis in adults. It is the second oral S1P receptor modulator to be approved in the US for this indication; ozanimod (Zeposia) was the first.

The FDA has approved Cobenfy (BMS), an oral fixed-dose combination of the muscarinic agonist xanomeline and the peripheral muscarinic antagonist trospium chloride, for treatment of schizophrenia in adults. It is the first antipsychotic drug to be approved in the US for treatment of schizophrenia that does not block dopamine receptors. This is the first approval for xanomeline; trospium has been available for many years for treatment of overactive bladder.

The Norplant System (Wyeth-Ayerst) for subdermal delivery of the synthetic progestin levonorgestrel was recently approved by the US Food and Drug Administration for use as a long-term contraceptive.

Risperidone (Risperdal - Janssen), a benzisoxazole derivative, is now available in the USA for treatment of schizophrenia and other psychotic disorders.

Rocuronium bromide (Zemuron - Organon), a new short-onset, intermediate-acting, nondepolarizing neuromuscular blocking drug, is now available in the USA for intravenous use. It is being promoted particularly for use in rapid endotracheal intubation.

Mycophenolate mofetil (CellCept - Roche) has been approved by the US Food and Drug Administration for oral use in preventing organ rejection in patients receiving allogeneic renal transplants. It is being promoted as an improvement over azathioprine (Imuran) for concurrent use with cyclosporine (Sandimmune; Neoral) and corticosteroids.