The FDA has approved a new plasma-derived von Willebrand factor/Factor VIII concentrate (Wilate – Octapharma) for treatment of spontaneous and trauma-induced bleeding episodes in patients with von Willebrand disease.

The FDA has approved ceftaroline fosamil (Teflaro – Forest), an intravenous (IV) cephalosporin, for treatment of acute bacterial skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA), and for treatment of community-acquired bacterial pneumonia in adults. It is the first beta-lactam antibiotic approved for treatment of MRSA.

The FDA has approved avanafil (Stendra – Vivus), an oral phosphodiesterase type-5 (PDE5) inhibitor, for treatment of erectile dysfunction. It is the fifth PDE5 inhibitor to be approved for this indication. Advertisements on Stendra’s website imply that it has a faster onset of action than other PDE5 inhibitors.

The FDA has approved Trumenba (Pfizer), a vaccine that protects against invasive meningococcal disease caused by Neisseria meningitidis serogroup B, for use in adolescents and young adults 10-25 years old.

The FDA has approved Glyxambi (Boehringer Ingelheim/Lilly), a fixed-dose combination of empagliflozin (Jardiance) and linagliptin (Tradjenta), for oral treatment of type 2 diabetes in adults. It is the first combination of a sodium-glucose co-transporter 2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor to be approved in the US.

Immune globulin (IgG) has been available for administration intravenously once every 3-4 weeks or subcutaneously once daily, once weekly, or every 2 weeks for treatment of primary immunodeficiencies. Now the FDA has approved human immune globulin 10% with recombinant human hyaluronidase (HyQvia – Baxter) for subcutaneous administration only every 3-4 weeks in adults with these disorders. The IgG component of HyQvia is identical to Gammagard Liquid, which was approved in 2005 for IV administration and in 2011 for SC administration.

The FDA has approved flibanserin (Addyi – Sprout) for treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) not caused by another medical or psychiatric condition, the effects of another drug, or relationship difficulties. Flibanserin is the first drug to be approved for treatment of HSDD. It is not approved for use in men or postmenopausal women. Previous FDA reviews of flibanserin in 2010 and 2013 did not result in approval.

The FDA has approved racemic amphetamine sulfate (Evekeo – Arbor) for oral treatment of attention-deficit/hyperactivity disorder (ADHD) in children ≥3 years old. It was also approved for treatment of narcolepsy in patients ≥6 years old and for short-term treatment of obesity in patients ≥12 years old.

Evolocumab (Repatha – Amgen), a subcutaneously injected PCSK9 inhibitor, has been approved by the FDA as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-cholesterol (LDL-C). It was also approved as an adjunct to diet and other LDL-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C. Evolocumab is the second PCSK9 inhibitor to be approved in the...

The FDA has approved the immune checkpoint inhibitor atezolizumab (Tecentriq – Genentech) for treatment of locally advanced or metastatic urothelial carcinoma and metastatic non-small cell lung cancer (NSCLC) that have progressed during or following platinum-based chemotherapy. Atezolizumab is the first programmed death-ligand 1 (PD-L1) blocking antibody to become available in the US. Two other immune checkpoint inhibitors, the programmed death receptor-1 (PD-1) inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda), are also approved for treatment of metastatic NSCLC, and...