Montelukast (Singulair - Merck) is an oral cysteinyl leukotriene D₄ receptor antagonist originally marketed for treatment of asthma. It was approved by the FDA in 2003 for treatment of seasonal allergic rhinitis and recently for use in perennial allergic rhinitis in adults and children ≥ 6 months old. Intranasal corticosteroids have generally been considered the most effective drugs available for prevention and treatment of allergic rhinitis.

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 Dyloject (Hospira), an IV formulation of the NSAID diclofenac sodium, for use in adults. It can be administered alone for treatment of mild to moderate pain or in combination with opioid analgesics for moderate to severe pain. Dyloject is the first injectable formulation of diclofenac to become available in the US.

The FDA has approved the use of ambrisentan (Letairis) and tadalafil (Adcirca) together for treatment of pulmonary arterial hypertension (PAH). It is the first 2-drug regimen to be approved for this indication.

The FDA has approved selexipag (Uptravi – Actelion), an oral selective prostacyclin IP receptor agonist, for treatment of pulmonary arterial hypertension (PAH). Treprostinil (Orenitram), an oral prostacyclin analog, was approved earlier for this indication.

The FDA has approved the human interleukin (IL)-12 and -23 antagonist ustekinumab (Stelara – Janssen Biotech) for treatment of moderately to severely active Crohn's disease in adults who were intolerant of or whose disease was unresponsive to treatment with immunomodulators or corticosteroids, or a tumor necrosis factor (TNF) inhibitor. Ustekinumab was approved earlier for treatment of psoriasis and psoriatic arthritis.

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 extended-release (ER) calcifediol (25-hydroxyvitamin D3; Rayaldee – Opko), a prohormone of calcitriol, the active form of vitamin D3. It is indicated for treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) who have serum total 25-hydroxyvitamin D levels <30 ng/mL.

The FDA has approved abemaciclib (Verzenio – Lilly), an oral cyclin-dependent kinase (CDK) 4/6 inhibitor, for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Abemaciclib is the third CDK 4/6 inhibitor to be approved in the US for this indication.

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.