The FDA has approved a new formulation (Exparel – Pacira) of the local anesthetic bupivacaine (Marcaine, and others) for use in the management of postsurgical pain in adults.

The FDA has approved a sublingual spray formulation of fentanyl (Subsys – Insys) for management of breakthrough pain in adult cancer patients who are receiving and are tolerant to opioid therapy (taking ≥60 mg/day of oral morphine or the equivalent). Fentanyl is already available in the US for intravenous, intrathecal, epidural, transdermal and transmucosal use.

Axitinib (Inlyta – Pfizer), an oral tyrosine kinase inhibitor, has been approved by the FDA for treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. It is the fourth oral tyrosine kinase inhibitor to be approved for treatment of advanced renal cell carcinoma.

The use of intracoronary stents in angioplasty procedures has improved both short- and long-term success rates. In recent years, drug-eluting stents (DESs) have largely replaced bare-metal stents (BMSs).

The FDA has approved the somatostatin analog pasireotide diaspartate (Signifor – Novartis) for treatment of adults with Cushing's disease (cortisol excess caused by an ACTH-secreting pituitary tumor) who are not candidates for pituitary surgery or for whom surgery has not been curative. Pasireotide is the first drug approved in the US specifically to treat Cushing's disease. The antiprogestin mifepristone (Korlym) was approved last year for control of hyperglycemia in patients with Cushing's syndrome, which includes other causes of hypercortisolism, such as exogenous steroids and...

The FDA has approved the oral multikinase inhibitor lenvatinib (Lenvima – Eisai) for treatment of locally recurrent or metastatic, progressive, differentiated thyroid cancer (papillary or follicular) refractory to radioactive iodine treatment.

With the widespread adoption of the CHA₂DS₂-VASc scoring system, oral anticoagulation therapy is now recommended for all patients ≥75 years old with nonvalvular atrial fibrillation. Atrial fibrillation has, however, been associated with an increased risk of falls, and older patients starting warfarin for atrial fibrillation have a high rate of hospitalization for intracranial bleeding. Many practitioners are reluctant, therefore, to prescribe an oral anticoagulant for elderly patients who are at high risk for falls.

The FDA has approved ferric pyrophosphate citrate solution (Triferic – Rockwell Medical) to maintain hemoglobin concentrations in adults with hemodialysis-dependent chronic kidney disease. Triferic is the first iron replacement product that is added into the hemodialysis solution at each dialysis procedure.

The nasal spray formulation of the corticosteroid fluticasone furoate is now available over the counter (OTC) as Flonase Sensimist Allergy Relief (GSK) in the same strength as the prescription product (Veramyst) for treatment of seasonal or perennial allergic rhinitis. It is the fourth intranasal corticosteroid to become available OTC.

The FDA has approved an extended-release intramuscular suspension formulation of the gonadotropin-releasing hormone (GnRH) agonist triptorelin (Triptodur – Arbor/Debiopharm) for twice-yearly treatment of central precocious puberty (CPP) in children ≥2 years old. Triptorelin has been available in the US for years as Trelstar for palliative treatment of advanced prostate cancer. Before the approval of Triptodur, Trelstar was used off-label for treatment of CPP.