The FDA has approved Dovato (ViiV), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay) and the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (Epivir, and generics), as a once-daily complete regimen for treatment of adults with HIV-1 infection who are antiretroviral-treatment naive and have no known substitutions associated with resistance to either drug. Dolutegravir/lamivudine is the first complete regimen to be approved by the FDA for initial treatment of HIV-1 infection that contains 2 rather than 3 antiretroviral...

The FDA has approved a fixed-dose combination of omeprazole, amoxicillin, and rifabutin (Talicia – RedHill) for treatment of Helicobacter pylori infection in adults. Talicia is the first rifabutin-based product to be approved for this indication.

The FDA has approved osilodrostat (Isturisa – Recordati), a cortisol synthesis inhibitor, for oral treatment of adults with Cushing's disease when surgical resection of the pituitary adenoma is not an option or has not been curative. Osilodrostat is the first cortisol synthesis inhibitor to be approved in the US for this indication. Other oral steroidogenesis inhibitors such as ketoconazole and metyrapone have been used off-label for this indication for many years.

View the Comparison Table: Some Oral Anticoagulants for VTE

Claims for the superiority of various calcium supplements are now appearing on television and in the print media. A high calcium intake combined with vitamin D can increase bone density and reduce the incidence of fractures in older women and probably also in men.

Finasteride and minoxidil continue to be the only drugs approved by the FDA to treat alopecia. Since these agents have different mechanisms of action, some clinicians have used both to treat hair loss in men.

A once-daily oral formulation of mesalamine (Lialda - Shire) was recently approved by the FDA for induction of remission in patients with mild to moderate ulcerative colitis.

The FDA has approved the use of ustekinumab (Stelara - Centocor Ortho Biotech), an interleukin antagonist given by subcutaneous (SC) injection for treatment of adults with moderate to severe plaque psoriasis. It is the first agent in its class for this indication; the other biologic agents for psoriasis are Tcell or tumor necrosis factor (TNF) inhibitors.

Two combinations of an inhaled corticosteroid with an inhaled long-acting beta2-agonist are approved by the FDA for use in patients with COPD: fluticasone/salmeterol (Advair Diskus) and budesonide/formoterol (Symbicort). A Medical Letter reader has questioned the safety of using corticosteroid inhalers in patients with this disorder. No single-agent inhaled corticosteroid inhaler is approved for this indication.

Telaprevir (Incivek – Vertex) and boceprevir (Victrelis – Merck) have been approved by the FDA for oral use in combination with peginterferon and ribavirin for treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adults with compensated liver disease. Both telaprevir and boceprevir were developed specifically to inhibit the NS3/4A proteases that cleave HCV encoded polyproteins of the genotype 1 virus.