Conivaptan hydrochloride (Vaprisol - Astellas), a vasopressin antagonist, has been approved by the FDA for short-term intravenous (IV) treatment of euvolemic hyponatremia in hospitalized patients. Euvolemic hyponatremia is most often caused by the syndrome of inappropriate ADH secretion (SIADH), or by hypothyroidism or adrenal insufficiency. The drug has not been approved for treatment of hypervolemic hyponatremia, which is associated with congestive heart failure (CHF), cirrhosis and renal disease. It should not be used in hypovolemic hyponatremia, such as occurs when fluid losses are...

The FDA has approved the sGC stimulator riociguat (rye" oh sig' ue at; Adempas – Bayer) for oral treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) following surgery or when surgery is not an option. It is the first drug to be approved for treatment of CTEPH.

The FDA has approved peramivir (Rapivab – BioCryst), an IV neuraminidase inhibitor administered as a single dose, for treatment of acute uncomplicated influenza in patients ≥18 years old who have had symptoms for no more than 2 days. Peramivir was available temporarily in the US during the 2009-2010 influenza season under an emergency use authorization for treatment of hospitalized patients. It has been available in some Asian countries since 2010. Peramivir is the third neuraminidase inhibitor to be approved in the US. Oseltamivir (Tamiflu), which is taken orally, and zanamivir...

The FDA has approved a second extended-release (ER) formulation of the oral opioid agonist hydrocodone (Hysingla ER – Purdue) for management of pain severe enough to require continuous long-term therapy and for which alternative treatment options are inadequate. Hysingla ER tablets have abuse-deterrent properties to discourage their misuse.

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 isavuconazonium sulfate (Cresemba – Astellas) for intravenous and oral treatment of invasive aspergillosis and invasive mucormycosis in adults. Isavuconazonium sulfate is a prodrug of isavuconazole, a broad-spectrum triazole antifungal.

The FDA has approved two new inhalers for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). Seebri Neohaler (Novartis) contains the long-acting anticholinergic glycopyrrolate. Utibron Neohaler (Novartis) contains both glycopyrrolate and the long-acting beta2-adrenergic agonist (LABA) indacaterol. Glycopyrrolate/indacaterol is the third fixed-dose combination of a long-acting anticholinergic and a LABA to become available in the US; umeclidinium/vilanterol (Anoro Ellipta) and tiotropium/olodaterol (Stiolto Respimat) were approved...

The FDA has approved Basaglar (Lilly/Boehringer Ingelheim), a "follow-on" 100 units/mL insulin glargine product similar to Lantus (Sanofi), which recently went off patent. A 300 units/mL formulation of insulin glargine (Toujeo) was approved in 2015.

The FDA has approved the monoamine oxidase type B (MAO-B) inhibitor safinamide (Xadago – US Worldmeds) as an adjunct to levodopa/carbidopa for management of "off" episodes in patients with Parkinson’s disease (PD). It is the first reversible MAO-B inhibitor to be approved for this indication. Selegiline (Eldepryl, and others) and rasagiline (Azilect, and generics), two irreversible MAO-B inhibitors, have been used alone and as adjuncts to levodopa/carbidopa for many years. Safinamide is not approved for use as monotherapy.

The FDA has approved betrixaban (Bevyxxa – Portola), a once-daily, oral, direct factor Xa inhibitor, for prophylaxis of venous thromboembolism (VTE) in adults hospitalized for an acute medical illness who have moderately or severely restricted mobility and other risk factors for VTE. Betrixaban is the first oral anticoagulant to be approved in the US for this indication.