Acetaminophen intravenous (IV) injection (Ofirmev) has been approved by the U.S. Food and Drug Administration (FDA) for relieving postsurgical fever and pain in patients receiving IV medications.1 It has been studied in orthopedic patients that underwent knee or hip replacement surgery and in abdominal laparoscopic surgeries. It is approved in adults and children aged two and older.
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Explore This IssueJanuary 2011
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Calcipotriene foam 0.005% (Sorilux) has been FDA approved for the topical treatment of plaque psoriasis in patients aged 18 years and older.2
Denosumab (Xgeva) has been FDA approved to prevent skeletal-related events in patients with solid tumor bone metastases (advanced cancer).3 Three late-stage clinical trials compared denosumab to zoledronic acid whereby denosumab was noninferior to the latter agent. The development of fractures was delayed for a longer period of time in denosumab-treated patients compared to zoledronic acid–treated patients with prostate or breast cancer. Zoledronic acid was superior to denosumab in delaying fracture time in patients with multiple myeloma.
Duloxetine capsules (Cymbalta) have been FDA approved to treat chronic musculoskeletal pain including chronic low back pain and osteoarthritis (OA).4
Immune globulin injection human 10% caprylate/chromatography purified (Gamunex-C) has been FDA approved in a subcutaneous formulation for the treatment of patients with primary immunodeficiency.5
Naltrexone extended-release intramuscular injection (Vivitrol) has been FDA approved as a once-monthly injection to treat and prevent relapse after patients with opioid dependence have undergone detoxification.6 Previously, naltrexone extended-release was approved to treat alcohol dependence. Side effects include nausea, tiredness, dizziness, headache, vomiting, decreased appetite, painful joints, and muscle cramps. Serious and severe injection site reactions have also occurred. It should only be administered by a physician using special administration needles that are provided with the product.
Pegloticase (Krystexxa) has been FDA approved for treating chronic gout in patients that are refractory to conventional treatments.7 A risk evaluation and mitigation strategy (REMS) is part of the product’s labeling due to the risk of severe infusion and allergic reactions. It should not be used in patients with glucose 6-phosphate dehydrogenase deficiency.
Risedronate 35 mg delayed-release tablets (Atelvia) have been FDA approved for the treatment of postmenopausal osteoporosis (PMO).8 They will be available in early 2011. This agent was only FDA approved to treat PMO. Dosing is once weekly immediately following breakfast with four ounces of water.9
Rozrolimupab (Sym001) has been granted orphan drug status for the treatment of primary immune thrombocytopenia and for Anti-RhD prophylaxis in the prevention of hemolytic disease in newborns.10 Rozrolimupab is a recombinant polyclonal antibody product. The agent is currently in phase II clinical trials.