Dirithromycin (Dynabac - manufactured by Lilly, distributed by Bock), an oral macrolide antibiotic chemically similar to erythromycin, clarithromycin (Biaxin) and azithromycin (Zithromax), has been approved for marketing by the US Food and Drug Administration (FDA).

Quetiapine (Seroquel - Zeneca), a dibenzothiazepine derivative, has been approved by the FDA for treatment of schizophrenia and other psychotic disorders. It is a new addition to the 'atypical' antipsychotics, which include olanzapine (Zyprexa - Medical Letter, 39:5, 1997), risperidone (Risperdal) and clozapine (Clozaril). Atypical antipsychotic drugs generally are less likely to cause extrapyramidal symptoms than older drugs such as haloperidol (Haldol, and others) or the phenothiazines.

Basiliximab (Simulect - Novartis) and daclizumab (Zenapax - Roche), two mouse/human monoclonal antibodies that block the interleukin-2 (IL-2) receptor on Tlymphocytes, have been approved by the FDA for use in the prevention of acute renal transplant rejection. Both drugs are used with cyclosporine (Sandimmune; Neoral) and corticosteroids. An all-murine anti-CD3 monoclonal antibody, muromonab-CD3 (Orthoclone OKT3), has been available in the USA for many years for treatment of transplant rejection, and has also been used with some success for prophylaxis (MI Wilde and KL Goa, Drugs,...

The FDA has approved spinosad 0.9% suspension (Natroba – ParaPro) for topical treatment of head lice infestation in patients ≥4 years old. It is available only by prescription.

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali – Novartis), which was approved by the FDA in 2017 for use with an aromatase inhibitor or fulvestrant for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, has now been approved for use with an aromatase inhibitor for adjuvant treatment of HR-positive, HER2-negative stage II or III early breast cancer at high risk of recurrence. Kisqali can be used in patients with node-positive or node-negative disease. The CDK 4/6...

Mirdametinib (Gomekli – SpringWorks Therapeutics), an oral kinase inhibitor, has been approved by the FDA for treatment of neurofibromatosis type 1 (NF1) in patients ≥2 years old who have symptomatic plexiform neurofibromas not amenable to complete resection. Mirdametinib is the second drug to be approved for this indication in the US and the first to be approved for use in adults. The oral kinase inhibitor selumetinib (Koselugo) was approved in 2020 for use in patients 2-17 years old.

Carteolol (Cartrol - Abbott) and penbutolol (Levatol - Reed & Carnrick), two oral beta-adrenergic blocking drugs, were recently approved by the US Food and Drug Administration for once-daily treatment of systemic hypertension. Both drugs are non-selective beta-blockers with mild partial agonist activity. Beta-blockers currently available in the USA for treatment of hypertension are listed in the table on the next page.

The FDA has approved the hedgehog pathway inhibitor sonidegib (Odomzo – Novartis) for oral treatment of locally advanced basal cell carcinoma that cannot be treated with surgery or radiation or has recurred following such treatment. Vismodegib (Erivedge), another oral hedgehog pathway inhibitor, was approved earlier for the same indication and also for treatment of metastatic basal cell carcinoma.

The FDA has approved subdermal implants of the partial opioid agonist buprenorphine (Probuphine – Titan) for maintenance treatment of opioid dependence in patients stabilized on low to moderate doses of transmucosal buprenorphine. Probuphine was designed to provide continuous low levels of buprenorphine for 6 months and to safeguard against illicit use of the drug.

Aspirin is now widely used for antithrombotic prophylaxis in patients who have had angina pectoris or a myocardial infarction and has also been tried in healthy people to prevent myocardial infarction. Recent studies have focused on increasingly lower doses of the drug. The use of aspirin in patients who have had transient ischemic attacks or strokes will not be discussed here.