Insulin detemir (Levemir - Novo Nordisk) is the second long-acting basal insulin analog to be marketed in the US for treatment of both type 1 and type 2 diabetes. Detemir differs from human insulin by the elimination of the amino acid threonine in position B30 and the addition of a 14-carbon fatty acid chain at position B29. Insulin glargine (Lantus), the first long-acting insulin analog, has been available since 2001 and is usually given once daily.1 NPH insulin is an intermediate-acting basal insulin given twice daily. Basal insulins are usually combined with prandial doses of a rapid-acting...

The FDA has approved tenofovir alafenamide (Vemlidy – Gilead) for treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease. It is the first single-drug product containing tenofovir alafenamide (TAF), a prodrug of the nucleotide reverse transcriptase inhibitor tenofovir, to become available; several combination products containing TAF are approved for treatment of HIV-1 infection. Tenofovir disoproxil fumarate (TDF; Viread – Gilead), another tenofovir prodrug, has been used for many years for treatment of chronic HBV infection; a generic...

The FDA has approved three new once-daily fixed-dose antiretroviral drug combinations for treatment of HIV-1 infection. Symfi and Symfi Lo (Mylan) contain the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz and the nucleoside reverse transcriptase inhibitors (NRTIs) lamivudine and tenofovir disoproxil fumarate (TDF) and were approved as complete antiretroviral regimens. Symfi Lo contains a lower dose of efavirenz than both Symfi and Atripla, a fixed-dose combination of efavirenz, TDF, and the NRTI emtricitabine that was approved in 2006. Cimduo (Mylan), which...

Eravacycline (Xerava – Tetraphase), a new synthetic tetracycline antibiotic, has been approved by the FDA for IV treatment of complicated intra-abdominal infections (cIAIs) in adults. Eravacycline is structurally similar to tigecycline (Tygacil, and generics), a broad-spectrum tetracycline approved by the FDA for IV treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired pneumonia. A higher rate of mortality has been reported with use of tigecycline compared to other antibacterial drugs; it should be used only...

Ketoconazole (Nizoral - Janssen), an imidazole antifungal drug widely used in a tablet formulation for treatment of systemic fungal infections (Medical Letter 36:16, 1994) and as a topical preparation for fungal skin infections, is also available as a shampoo for treatment of seborrheic dandruff. The shampoo is sold only by prescription.

Linagliptin (Tradjenta – Boehringer Ingelheim/Lilly), a third oral dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor, was recently approved by the FDA for treatment of type 2 diabetes, either alone or in combination with metformin, a sulfonylurea or pioglitazone

The FDA has approved ibalizumab-uiyk (Trogarzo – Theratechnologies/TaiMed), a CD4-directed monoclonal antibody, for IV treatment of multidrug-resistant HIV-1 (MDR-HIV) infection in heavily antiretroviral-experienced adults with treatment failure on their current regimen. Ibalizumab-uiyk is the first biologic drug to be approved by the FDA for treatment of HIV-1 infection.

The FDA has approved ciltacabtagene autoleucel (Carvykti – Janssen), a B-cell maturation antigen (BCMA)-directed genetically-modified cellular product, for treatment of relapsed or refractory multiple myeloma in adults who received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Carvykti is an individualized cellular product prepared from the patient's own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. Idecabtagene...

The US FDA has approved use of palivizumab for prevention of respiratory syncytial virus (RSV) infection in high-risk infants and children.

A nasal spray formulation of cyanocobalamin (Nascobal – Questcor) has been approved by the FDA for maintenance treatment of vitamin B12 deficiency. Nascobal is already available as an intranasal gel. Vitamin B12 deficiency, diagnosed by elevated serum concentrations of methylmalonic acid with or without elevated serum homocysteine and low serum B12 concentrations (<200 pg/mL), is common in older patients.1Since intestinal absorption of B12 may be impaired, the usual maintenance treatment of deficiency is intramuscular injection of the vitamin in doses of 1 mg every 4 weeks (after more...