The FDA has approved Eloctate (Biogen), a recombinant factor VIII Fc fusion protein with an extended half-life, for use in adults and children with hemophilia A. Eloctate is indicated for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. It is the first antihemophilic factor VIII Fc fusion protein to be approved for hemophilia A.

In 2014, the US Advisory Committee on Immunization Practices (ACIP) recommended that all adults 65 years old and older being vaccinated against pneumococcus for the first time receive the pneumococcal conjugate vaccine (PCV13) followed 6 to 12 months later by the pneumococcal polysaccharide vaccine (PPSV23)(Med Lett Drugs Ther 2014; 56:102). In June 2015, the ACIP changed the recommended interval between the two vaccines to >1 year for immunocompetent adults ≥65 years old (MMWR Morbid Mortal Wkly Rep 2015; 674:944). Separating the vaccines by a year or more may improve the immune response...

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 naloxegol (Movantik – AstraZeneca), a pegylated derivative of the opioid antagonist naloxone, for oral treatment of opioid-induced constipation in adults with chronic noncancer pain. It is the only oral opioid antagonist approved for this indication in the US.

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.

Development of abuse-deterrent opioid products, including reformulation of existing products, has become a priority for drug manufacturers and public health advocates. Three available opioid formulations, OxyContin (Purdue), Embeda (Pfizer), and Hysingla ER (Purdue), now include claims of abuse deterrence in their package inserts.

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 the ReShape Integrated Dual Balloon System (ReShape Medical) and the Orbera Intragastric Balloon System (Apollo Endosurgery) for up to 6 months of use in adults with a BMI of 30-40 who have not been able to maintain weight loss with a weight loss program and, for ReShape, who have at least one obesity-related comorbidity. Both devices have been available in the European Union and elsewhere for years (20 years for Orbera). Three other devices, the LAP-Band, the Realize adjustable gastric band, and the Maestro Rechargeable System, are FDA-approved for long-term treatment of...

The FDA has approved another fixed combination of the antibiotic clindamycin phosphate and the oxidizing agent benzoyl peroxide (Onexton Gel 1.2%/3.75% – Valeant) for topical treatment of acne in patients ≥12 years old. Topical products containing the same drugs have been available for many years. Onexton Gel contains a new strength of benzoyl peroxide.

The FDA has approved the subcutaneously injected PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor alirocumab (Praluent – Sanofi/Regeneron) 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 not approved for general use in statin-intolerant patients. Alirocumab is the first PCSK9 inhibitor to be approved in the US. Evolocumab (Repatha – Amgen), another PCSK9 inhibitor, was recently...