Drug Topics - April 14, 2008 - (Page 64)

64 DRUG TOPICS APRIL 14, 2008 www.drugtopics.com > > >New Products Rx NEW DRUGS Arcalyst Injection (rilonacept) for subcutaneous use, from Regeneron, www.regeneron.com, has received FDA approval. The interleukin-1 blocker is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes, including Familial Cold Auto-inflammatory Syndrome, and Muckle-Wells Syndrome in adults and children 12 and older. Wyeth, www.wyeth.com, has announced the approval of Xyntha (Antihemophilic Factor [Recombinant], Plasma/Albumin-Free). It is a recombinant factor VIII product indicated for the control and prevention of bleeding episodes in patients with hemophilia A and for surgical prophylaxis in patients with hemophilia A. NEW INDICATIONS Avastin (bevacizumab) from Genentech, has been approved by the FDA for use in combination with paclitaxel chemotherapy, for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer. Avastin, www.avastin. com, was approved under the FDA’s accelerated approval program, which allows the agency to approve products for cancer or other life-threatening diseases based on initial positive clinical data. FDA approval went against the recommendation of its own advisory panel. Abbott, www.abbott.com, has received a couple of new approvals recently. Humira (adalimumab) is now approved as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older. Simcor is a fixed-dose combination of Niaspan (niacin extended-release) and simvastatin. Simcor is approved for use along with diet to lower levels of total cholesterol, LDL cholesterol, and triglycerides, and to raise HDL cholesterol in patients with complex lipid disease. Abilify Tablets and Oral Solution (aripiprazole), www.abilify.com, are now approved for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, with or without psychotic features in pediatric patients 10 to 17 years old. Bristol-Myers Squibb and Tokyo-based Otsuka Pharmaceutical partnered in their development. The FDA added descriptions of two new regimens for Merck’s Janumet (sitagliptin/metformin HCl). Information has been added for Janumet (www. janumet.com) that describes using the DPP-4 inhibitor/biguanide combination drug as initial therapy in diabetes patients who are inadequately controlled with diet and exercise alone, and as an add-on therapy to a sulfonylurea when the combination of a sulfonylurea and metformin does not provide adequate glycemic control. Nexium (esomeprazole magnesium) has been approved for short-term use in children ages one to 11 years for the treatment of gastroesophageal reflux disease (GERD). The approval covers AstraZeneca’s Nexium, www.purplepill.com, in two forms, a delayed-release capsule and liquid formulation. Nexium is approved in 10 or 20 mg daily for children one to 11 years old and in doses of 20mg or 40mg for pediatric patients 12 to 17 years of age. Luvox CR (fluvoximine maleate), which is distributed by Jazz Pharmaceuticals (www.jazzpharma ADVERTISERS INDEX BYSTOLIC (Forest Laboratories) INSERT CORPORATE (AmerisourceBergen) 65 OPTIVE (Allergan Inc.) 3 CORPORATE (Eisai) 53 CORPORATE (Mylan Pharmaceuticals) 9 CORPORATE (QS/1 Data Systems) 1 CORPORATE (Reese Pharmaceutical) 32 CORPORATE (Stericycle) 31 DORIPENEM(Ortho-McNeil Pharmaceutical) HSE INSERT EVAMIST (Ther-Rx Corp.) 36-39 FLEXPEN (Novo Nordisk) BC FREESTYLE LITE (Abbott Laboratories) 67 LEXAPRO (Forest Laboratories) INSERT, 29 LICEMD (Combe Inc.) IBC LUVOX CR (Jazz Pharmaceuticals) 23-26 METOPROLOL SUCCINATE (Ethex Corp.) 71 METRONIDAZOLE (Fougera) 11 MURINE EARIGATE (Prestige Brands) 5 OXYCONTIN (Purdue Pharma) 13-14 RXKEY (KeyCentrix) 17,BRC SULAR (Sciele Pharma) 41-42 TAMPALERT (EPS) HSE7 TOPAMAX (Ortho-McNeil Pharmaceutical) 46-49 ZADITOR (Novartis) IFC ZOSYN (Wyeth Pharmaceuticals) HSE3-5 IFC-Inside front cover IBC-Inside back cover BC-Back cover http://www.drugtopics.com http://www.avastin.com http://www.avastin.com http://www.regeneron.com http://www.wyeth.com http://www.abbott.com http://www.abilify.com http://www.janumet.com http://www.janumet.com http://www.purplepill.com http://www.jazzpharmaceuticals.com

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Drug Topics - March 14, 2008 Contents Latebreakers Letters: Students Need Grounding in Chemistry Pharmacy Directors Wary of Heparin Shortages Some E-prescribing Standards are Ready to Go, Others are Not News Briefs Nanotechnology: Big Stakes in a Small World Pay for Performance is Coming to Pharmacy Patient Safety Organizations Still Very Much in Planning Stage Reconciling Medications in Specialty Patients Poses More Challenges Pharmacy Outsourcing Still Much in Use by Hospitals Studied Extensively, New Drug-Eluting Stent Said to be Very Safe Prevention is Key in Treating C. Difficile Infections E-prescribing Grows in Massachusetts, but Other States Lag Behind Active Metabolite Gives New Life to Antidepressant NSAIDS not Recommended for Long-term Use in Osteoarthritis This Time R.Ph.s and States Are Ready for Tamper-Resistant Rx Pads Cardinal Caught Between DEA and Pharmacies over Diversion Control Medicating Kids: Still More Questions than Answers Schnucks Pharmacy: Drug Topics' Chain of the Year Panel Will Ask for a System for R.Ph. Practice Across State Lines FDA Safety Page: How to use Fentora Safely The Shining OTC/HBC Stars of 2007 Take a Look at These OTCs for Eye Health Technology Update: Google Offers a Sneak Peak at its Electronic Records Initiative Recent Advancements in HIV/AIDS Treatment New Products Advertisers Index Classified Viewpoint: Are State Boards of Pharmacy Abusing Their Power?

Drug Topics - April 14, 2008

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