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.

Sodium phenylbutyrate, an "orphan drug,"has recently been marketed for the treatment of patients with urea cycle disorders caused by a deficiency in one of the following hepatic enzymes: carbamyl phosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). Urea cycle disorders are rare; they occur in one of every 10,000 births.

Rifapentine, a long-acting analog of rifampin developed in the 1960's, has received an accelerated approval from the FDA for oral use, with at least one other drug, in the treatment of pulmonary tuberculosis.