Monica Holmberg, PharmD, BCPS

The FDA has approved Utibron Neohaler oral inhalation powder for long-term maintenance treatment of airflow obstruction in patients with COPD.

The FDA has approved Belbuca buccal film for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The FDA has approved Tresiba (insulin degludec injection) to improve glycemic control in adults with diabetes mellitus.

The FDA has approved Repatha (evolocumab) injection, a human monoclonal antibody that works to decrease low-density lipoprotein cholesterol.

The FDA has approved Symplmed's Prestalia (perindopril arginine and amlodipine besylate) tablets for the treatment of hypertension to lower blood pressure in patients who are not adequately controlled with monotherapy or as initial therapy in patients likely to need multiple medications to achieve their blood pressure (BP) goals.1 An estimated 1 in 3 Americans have hypertension, about half of whom have it controlled.

The FDA has approved Amgen's Corlanor to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic HF with left ventricular ejection fraction.

The FDA has approved Shire's Vyvanse for the treatment of moderate to severe binge eating disorder.

The FDA has approved Merck's Belsomra (suvorexant), a Schedule IV substance, for the treatment of insomnia, as characterized by difficulties with sleep onset and/or sleep maintenance.

The FDA has approved Impax Pharmaceuticals' Rytary for the treatment of Parkinson's disease, postencephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.

The FDA has approved Merck's Keytruda injection for the treatment of patients with unresectable or metastatic melanoma and disease progression following administration of ipilimumab and, if positive for the BRAF V600 mutation, a BRAF inhibitor.

The FDA has approved GlaxoSmithKline's Tanzeum (albiglutide) subcutaneous injection as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The FDA has approved Xigduo XR (dapagliflozin and metformin HCl extended-release tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

The FDA has approved Astra-Zeneca's Movantik (naloxegol) tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic noncancer pain.

Epaned (enalapril maleate powder for oral solution) has been approved by the FDA for the treatment of hypertension in patients aged 1 month and older.

The FDA has approved Anoro Ellipta (GlaxoSmithKline and Theravance, Inc) for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease.

Xgeva has received FDA approval for a new indication, the treatment of adults and skeletally mature adolescents with giant cell tumor of bone.

The FDA has approved Fetzima (levomilnacipran extended-release capsules) for the treatment of major depressive disorder in adult patients.

Fycompa (perapanel) tablets are approved for the treatment of partial-onset seizures in patients 12 years and older.

Xeljanz (tofacitnib) tablets are indicated for adults with moderately to severely active rheumatoid arthritis who have failed methotrexate.

Vascepa (icosapent ethyl) is approved as an adjunct to diet and exercise to reduce triglycerides in adults with severe hypertriglyceridemia.

The FDA approved Gilead Sciences, Inc.'s Truvada (emtricitabine 200 mg/tenofovir disproxil fumarate 300 mg) in combination with safer sex practices for pre-exposure prophylaxis.

Truvada (emtricitabine/tenofovir disoproxil fumarate) was approved for prophylaxis to reduce the risk of HIV-1 infection in adults.

Linzess (linaclotide) is approved for treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation.