The FDA has approved Incruse Ellipta (GSK), a single-agent inhaler containing the long-acting anticholinergic umeclidinium, for once-daily maintenance treatment of chronic obstructive pulmonary disease (COPD). Umeclidinium was initially approved in combination with the long-acting beta₂-adrenergic agonist vilanterol as Anoro Ellipta.

The FDA has approved a subcutaneously injected formulation of recombinant human parathyroid hormone (Natpara – NPS) as an adjunct to calcium and vitamin D to control hypocalcemia in adults with hypoparathyroidism. Natpara is an 84-amino acid single-chain polypeptide identical to native parathyroid hormone. It is the first parathyroid hormone formulation to be approved for this indication.

The FDA has approved Liletta, an intrauterine device (IUD) that releases the synthetic progestin levonorgestrel, for prevention of pregnancy for up to 3 years. The fourth IUD to be approved in the US, and the third that releases levonorgestrel, Liletta is comarketed by Actavis and Medicines360, a nonprofit women's health pharmaceutical company. The wholesale cost of Liletta is similar to that of other IUDs (see Table 1), but the manufacturer offers programs that significantly reduce the cost for commercially-insured patients and clinics serving low-income women.

An injectable foam formulation of the sclerosing agent polidocanol (Varithena – Provensis/BTG) has been approved by the FDA for treatment of incompetent veins and visible varicosities of the great saphenous vein system. It is the first foam therapy to be approved for this indication, but polidocanol and other sclerosants have been used for years as foam formulations compounded by physicians. Polidocanol is also available in a liquid formulation (Asclera) to treat smaller veins. Sodium tetradecyl sulfate (Sotradecol) is FDA-approved in a liquid formulation for use in...

The FDA has approved panobinostat (Farydak – Novartis), an oral histone deacetylase (HDAC) inhibitor, for use in combination with bortezomib (Velcade) and dexamethasone for treatment of patients with multiple myeloma who have received at least 2 prior therapies including bortezomib and an immunomodulatory drug. It is the first HDAC inhibitor to be approved for this indication.

The FDA has approved a sumatriptan iontophoretic transdermal system (Zecuity – Teva) for acute treatment of migraine in adults. Sumatriptan, the first of seven serotonin receptor antagonists (triptans) approved for this indication, is the most frequently prescribed migraine treatment in the US. It is also available in oral, intranasal, and injectable formulations.

The FDA has approved daclatasvir (Daklinza – BMS), an oral direct-acting antiviral drug, for use with sofosbuvir (Sovaldi) for treatment of chronic hepatitis C virus (HCV) genotype 3 infection. Daclatasvir is the first drug approved for this indication that does not require the addition of interferon or ribavirin. It is approved in Japan and Europe in combination with other drugs for treatment of HCV genotypes 1-4.

The FDA has approved Bexsero (Novartis/GSK), a vaccine that protects against invasive meningococcal disease caused by Neisseria meningitidis serogroup B. It is the second serogroup B meningococcal vaccine to be approved in the US; Trumenba was the first. Both vaccines are approved for use in persons 10-25 years old. Bexsero is approved in Europe, Canada, and Australia for use in children as young as 2 months old.

The FDA has approved mepolizumab (Nucala - GSK), a subcutaneously injected humanized interleukin-5 (IL-5) antagonist monoclonal antibody, for maintenance treatment of severe asthma in patients ≥12 years old who have an eosinophilic phenotype.

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.