The FDA has approved the mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor cobimetinib (Cotellic – Genentech) for use in combination with the BRAF kinase inhibitor vemurafenib (Zelboraf) for treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.

The FDA has approved a subcutaneously administered 20% solution of human immune globulin (Cuvitru – Shire) for replacement therapy in patients ≥2 years old with a primary humoral immunodeficiency. Hizentra (CSL Behring), another subcutaneously administered 20% immune globulin solution, was approved in 2010 for the same indication. The IgG component of Cuvitru is similar to that of Gammagard Liquid and HyQvia, two subcutaneously administered 10% immune globulin formulations also manufactured by Shire and approved for treatment of primary...

The FDA has approved an adjuvanted, recombinant varicella zoster virus (VZV) vaccine (Shingrix – GSK) for prevention of herpes zoster (shingles) in adults ≥50 years old. Shingrix is the second herpes zoster vaccine to be approved in the US; Zostavax, a live-attenuated VZV vaccine approved for the same indication, has been available since 2006.

The FDA has approved Duaklir Pressair (Circassia), a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide and the longacting beta₂-adrenergic agonist (LABA) formoterol fumarate, for maintenance treatment of chronic obstructive pulmonary disease (COPD). Aclidinium/formoterol is the fifth LAMA/LABA combination to be approved in the US for this indication.

The FDA has approved Twirla (Agile Therapeutics), a transdermal contraceptive patch containing the estrogen ethinyl estradiol and the progestin levonorgestrel, for use in women with a BMI <30 kg/m². It is the second contraceptive patch to become available in the US; Xulane, a patch that delivers ethinyl estradiol and the progestin norelgestromin, has been available since 2014.

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 1.5% cream formulation of the Janus kinase (JAK) inhibitor ruxolitinib (Opzelura – Incyte) has been approved by the FDA for topical treatment of nonsegmental vitiligo (NSV) in patients ≥12 years old. Opzelura is the first product to be approved by the FDA for this indication. It was previously approved for treatment of atopic dermatitis.

Varenicline tartrate (Chantix - Pfizer) is now available for oral treatment of tobacco dependence. Some other drugs for this indication are listed in this article.

The goal of pharmacologic treatment for type 2 diabetes is to achieve and maintain a near-normal glycated hemoglobin (A1C) concentration while minimizing hypoglycemia; an A1C goal of <7% is recommended for most patients to prevent or reduce the microvascular complications of diabetes (retinopathy, nephropathy, neuropathy). An A1C target of <8% may be appropriate for patients who are older, have comorbid conditions, or are at risk for serious hypoglycemia-associated adverse events.

Lepirudin (Refludan - Hoechst Marion Roussel), a direct inhibitor of thrombin, has been approved by the FDA for use as an anticoagulant in patients with heparin-induced thrombocytopenia and thromboembolic complications.