The FDA has approved Byvalson (Allergan), a fixed-dose combination of the beta blocker nebivolol (Bystolic) and the angiotensin receptor blocker (ARB) valsartan (Diovan, and generics), for treatment of hypertension. It is the only combination product that contains nebivolol, and the first to combine a beta blocker with an ARB.

The FDA has approved daclizumab (Zinbryta – Biogen/Abbvie), an interleukin-2 (IL-2) receptor blocking monoclonal antibody, for treatment of adults with relapsing forms of multiple sclerosis (MS). It is the first subcutaneously injected monoclonal antibody to be approved for treatment of MS.

The FDA has approved AspireAssist (Aspire Bariatrics), a weight-loss device that permits patients to drain a portion of their stomach contents through a gastrostomy tube into a toilet after each meal. It is approved for long-term use in combination with lifestyle modifications in adults ≥22 years old who have a body mass index (BMI) of 35 to 55 and have not been able to achieve and maintain weight loss with nonsurgical therapy.

The FDA has approved a 5% ophthalmic solution of lifitegrast (Xiidra – Shire), a lymphocyte function-associated antigen-1 (LFA-1) antagonist, for treatment of the signs and symptoms of dry eye disease. Lifitegrast is the first LFA-1 antagonist to be approved for any indication in the US.

The FDA has approved Vaxchora (PaxVax), a single-dose, oral, live-attenuated cholera vaccine, to protect against disease caused by Vibrio cholerae serogroup O1 in adults 18-64 years old traveling to cholera-affected areas. Vaxchora is the only cholera vaccine available in the US. A whole-cell killed injectable vaccine was previously approved, but is no longer available in the US.

The FDA has approved sugammadex (Bridion – Merck), a selective relaxant binding agent, for reversal of rocuronium- or vecuronium-induced neuromuscular blockade in adult surgical patients. It is the first selective relaxant binding agent to be approved in the US. Sugammadex has been available in the European Union, Japan, and elsewhere for several years. Previous FDA reviews of sugammadex did not result in approval because of concerns about a risk of anaphylaxis and other hypersensitivity reactions with its use.

The FDA has approved Onzetra Xsail (Avanir), a nasal powder formulation of sumatriptan, for acute treatment of migraine in adults. Nasal spray formulations of sumatriptan (Imitrex) and zolmitriptan (Zomig) have been available for many years.

Brivaracetam (Briviact – UCB), an analog of levetiracetam (Keppra, and others), has been approved by the FDA for adjunctive treatment of partial-onset seizures in patients ≥16 years old. New drugs for epilepsy are often approved initially only as adjunctive treatment for partial seizures.

The FDA has approved subdermal implants of the partial opioid agonist buprenorphine (Probuphine – Titan) for maintenance treatment of opioid dependence in patients stabilized on low to moderate doses of transmucosal buprenorphine. Probuphine was designed to provide continuous low levels of buprenorphine for 6 months and to safeguard against illicit use of the drug.

At the same time that the FDA announced it was strengthening existing warnings about the risk of acute kidney injury in patients with type 2 diabetes treated with the sodium-glucose co-transporter 2 (SGLT2) inhibitors canagliflozin (Invokana, and others) and dapagliflozin (Farxiga, and others), a study was published showing that the third SGLT2 inhibitor, empagliflozin (Jardiance, and others), slowed the progression of renal dysfunction in patients with type 2 diabetes.