Zoledronic acid (Zometa), a new bisphosphonate, has been approved by the FDA for intravenous (IV) treatment of hypercalcemia of malignancy.

The FDA has approved Duexis (Horizon), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the H2-receptor antagonist (H2RA) famotidine, for symptomatic relief of osteoarthritis and rheumatoid arthritis and to decrease the risk of developing gastric and duodenal ulcers in patients at risk for NSAID-associated ulcers. Vimovo, a combination of the NSAID naproxen and the proton pump inhibitor (PPI) esomeprazole, is also approved by the FDA for prevention of NSAID-associated gastric ulcers.

The FDA has approved belatacept (bel at´ a sept; Nulojix – Bristol-Myers Squibb) for prevention of organ rejection in adult patients receiving a kidney transplant.

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 FDA has approved vismodegib (vis moe deg´ ib; Erivedge – Genentech), the first hedgehog (Hh) pathway inhibitor, for oral treatment of metastatic basal cell cancer, locally advanced basal cell carcinoma that has recurred after surgery, or locally advanced basal cell carcinoma in adults who are not candidates for surgery or radiation.

Most patients with end-stage renal disease develop hyperphosphatemia, which can lead to secondary hyperparathyroidism, vascular calcification, and cardiovascular mortality. The FDA has approved sucroferric oxyhydroxide (Velphoro – Fresenius Medical Care), a chewable phosphate binder, for treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. It is the first iron-based phosphate binder to be approved for this indication.

The FDA has approved talimogene laherparepvec (Imlygic – Amgen), a genetically modified herpes simplex virus, for intralesional treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma that has recurred following surgery. It is the first oncolytic virotherapy to become available in the US.

Icosapent ethyl (Vascepa – Amarin), the ethyl ester of eicosapentaenoic acid (EPA), has been approved by the FDA for use as an adjunct to maximally tolerated statin therapy to reduce the risk of major adverse cardiovascular events in adults with hypertriglyceridemia (≥150 mg/dL) who have either established cardiovascular disease (CVD) or diabetes and ≥2 additional risk factors for CVD. It is the only omega-3 polyunsaturated fatty acid (PUFA) product to be approved in the US for this indication. Icosapent ethyl and two other omega-3 PUFA prescription products (Lovaza, Epanova),...