Pharmacy & Therapeutics - March 2008 - (Page 131) NEW DRUGS NEW DRUGS Generic Approvals Alendronate for Osteoporosis The U.S. Food and Drug Administration (FDA) has approved the first generic versions of Merck’s Fosamax (alendronate sodium) to treat osteoporosis. Teva Pharmaceuticals will make the tablets in three once-daily strengths (5, 10, and 40 mg) and in two once-weekly strengths (35 and 70 mg). Barr Laboratories will manufacture a 70-mg onceweekly dose. (Source: FDA, February 8, 2008.) DRUG NEWS need for hand–breath coordination. A numeric dose counter is also provided. This product should not be used to treat sudden asthma attacks. Its longterm effects on final adult height are unknown. (Source: Schering-Plough, February 4, 2008, www.spfiles.com/piasmanex.pdf.) The new approval was based on data from more than 640 patients with mixed dyslipidemia and type II hyperlipidemia. In the SEACOAST trial, patients receiving Simcor 1,000/20 mg achieved significant cholesterol improvements over and above what simvastatin 20 mg alone provided. Simcor also reduced triglycerides by an additional 27%, compared with 15% with simvastatin 20 mg alone. (Source: Abbott, February 18, 2008.) Adalimumab (Humira) For Juvenile Rheumatoid Arthritis Abbott has received approval to market adalimumab (Humira) to reduce signs and symptoms of moderately to severely active juvenile rheumatoid arthritis (JRA), also known as polyarticular juvenile idiopathic arthritis, in children four years of age and older. This is the first biologic treatment to receive FDA approval for this condition since 1999 and the first to be given by injection at home once every two weeks. It was once believed that most children eventually outgrow JRA, but 25% to 75% of children still have active disease into adulthood. JRA is the sixth disease indication for which adalimumab has received approval since 2002. (Source: Abbott, February 22, 2008.) Xyntha for Hemophilia The FDA has licensed a therapy for hemophilia A, which affects mostly males. Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free (Wyeth) is a genetically engineered version of factor VIII, a protein needed for blood clotting. Factor VIII (antihemophilic factor) is absent or decreased in these patients. Xyntha is indicated to control and prevent bleeding, which can occur spontaneously or after an accident or injury in patients with hemophilia A, and to prevent surgical bleeding in these patients. (Sources: FDA; Wyeth, February 21, 2008.) Bleomycin for Chemotherapy APP Pharmaceuticals has announced the FDA’s approval of its Abbreviated New Drug Application (ANDA) for Bleomycin Sulfate for Injection, USP, the equivalent of Bristol-Myers Squibb’s Blenoxane. APP’s product is AP-rated, preservative-free, and latex-free, and it is bar-coded at the individual unit-of-use. This medication should be considered a palliative treatment. As a single agent or in combination with other approved chemotherapeutic agents, it has been useful in the management of squamous cell carcinoma, lymphomas, testicular carcinoma, and malignant pleural effusion. (Source: APP, February 8, 2008.) NEW INDICATIONS Inhaled Asthma Drug (Asmanex) For Young Children The FDA has approved ScheringPlough’s mometasone furoate inhalation powder (Asmanex Twisthaler) at a dose of 110 mcg for the maintenance treatment of asthma as a preventive therapy in patients 4 to 11 years of age. The 220-mcg dose of Asmanex, an inhaled corticosteroid, was approved on March 31, 2005, for the same indication in patients 12 years of age and older. Inhaled corticosteroids are considered the preferred foundation therapy for initiating long-term control in children with persistent asthma. The Twisthaler has a device that does not use a propellant, thus eliminating the Bevacizumab for Breast Cancer Genentech, Inc., has announced the FDA’s accelerated approval of bevacizumab (Avastin) combined with paclitaxel chemotherapy, for patients who have not received chemotherapy for metastatic HER-2–negative breast cancer. The approval is based on a phase 3 study (E2100) showing that this combination resulted in a 52% reduction in the risk of disease progression or death, compared with paclitaxel alone, and in a doubling in progression-free survival. A full review of other trials is needed before the accelerated approval can be converted to a full approval. (Source: Genentech, February 22, 2008.) Niaspan/Simvastatin (Simcor) For Lowering Cholesterol Abbott Labs has received the FDA’s approval to market Sincor, the first fixeddose combination of two cholesterol therapies, Niaspan (niacin extended-release) and simvastatin (Zocor). Simcor is approved for use along with diet to reduce levels of elevated total cholesterol, low-density lipoprotein-cholesterol (LDL-C) and triglycerides, and to raise HDL-C levels in patients with complex lipid disease when simvastatin or Niaspan alone is not considered adequate. Vol. 33 No. 3 • March 2008 • P&T® 131 http://www.spfiles.com/piasmanex.pdf
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