Drug Topics - May 12, 2008 - (Page 77)

www.drugtopics.com MAY 12, 2008 DRUG TOPICS 77 New Products <<< RX NEW DRUG The FDA has approved GlaxoSmithKline’s (www. gsk.com) Rotarix (Rotavirus Vaccine, live, oral) for the prevention of rotavirus gastroenteritis in infants. The Centers for Disease Control & Prevention Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians recommend that infants receive routine rotavirus vaccination in order to prevent rotavirus gastroenteritis. Rotarix will be commercially available in the second half of this year. Genzyme has launched the phosphate binder Renvela (sevelamer carbonate) for dialysis patients. Renvela, www.renvela.com, is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Sevelamer carbonate is contraindicated in patients with hypophosphatemia or bowel obstruction. NEW INDICATIONS Orencia (abatacept) from Bristol-Myers Squibb (www.orencia.com) has been approved by the FDA for reducing signs and symptoms in pediatric patients six years and older with moderately to severely active polyarticular juvenile idiopathic arthritis. Orencia may be used as monotherapy or concomitantly with methotrexate, but should not be administered concomitantly with tumor necrosis factor antagonists and is not recommended for use concomitantly with biologic rheumatoid arthritis (RA) therapy, such as anakinra. Orencia was previously approved for adults who have not been helped by other RA therapies. Eisai’s Aloxi (palonosetron hydrochloride) injection, www.aloxi.com, is now approved for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated. Aloxi was first approved in 2003 for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of both moderately and highly emetogenic chemotherapy. The new indication is based on one double-blind Phase III study that evaluated the efficacy of three doses of Aloxi compared with placebo for the prevention of PONV. NEW LABEL The FDA has approved label changes for the combination therapy of Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin, USP) for chronic hepatitis C. The new label for the Schering-Plough’s (www.scheringplough.com) medications recommends weight-based dosing of Rebetol (800-1400 mg daily) based on patient body weight. The revised label also recommends a shorter, 24-week course of the combination therapy for patients with chronic hepatitis C virus (HCV) genotype 2 or 3. The label changes are based on the results of the WIN-R trial hepatitis C study conducted in more than 4,900 patients. In the United States, Pegintron is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and who are at least 18 years of age. Novo Nordisk has received approval from the FDA for new labeling for NovoLog (insulin aspart [rDNA origin] injection) for continuous subcutaneous insulin infusion (CSII) by external insulin pump in pediatric ADVERTISERS INDEX ACIPHEX (Pricara) INSERT ACTOS (Takeda Pharmaceuticals) INSERT,37 ALENDRONATE (Teva Pharmaceuticals) 13 AMITIZA (Takeda Pharmaceuticals) 39,57 CEFEPIME INJECTION (Baxter) HSE11 CORPORATE (Actavis US) 11 CORPORATE (Cardinal Health) IFC CORPORATE (EPS Inc) 37 CORPORATE (Fougera) 8-9 CORPORATE (Mylan Pharmaceuticals) 7 CORPORATE (Parata Systems) 45 CORPORATE (QS/1) 51 CORPORATE (ScriptPro) 3 CORPORATE (United Drugs) 52 CORPORATE (Watson Pharmaceuticals) 46-47 CULTURELLE (Amerifit Inc.) 55 EVAMIST (Ther-Rx Corp.) 18-21 FLECTOR (Alpharma) 27-28 FLEXPEN (Novo Nordisk) BC FREESTYLE (Abbott Laboratories) 49 IVYBLOCK (Hylands) 83 LEXAPRO (Forest Laboratories) INSERT,25 LUVOX CR (Jazz Pharmaceuticals) 59-62 OXYCONTIN (Purdue Pharma) 75-76 PEDIA-LAX (C B Fleet) 35 PRILOSEC OTC (Procter & Gamble) IBC SULAR (Sciele Pharma) 15-16 THROMBIN (King Pharmaceuticals) HSE7-8 TOPAMAX (Ortho-McNeil) 30-33 TRICOR (Abbott Laboratories) 43 ZOSYN (Wyeth Pharmaceuticals) HSE 3-5 ZYPREXA (Eli Lilly & Co.) 1 ZYRTEC (McNeil Consumer) 23 IFC-Inside front cover IBC-Inside back cover BC-Back cover http://www.drugtopics.com http://www.gsk.com http://www.gsk.com http://www.renvela.com http://www.orencia.com http://www.aloxi.com http://www.scheringplough.com http://www.scheringplough.com

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Drug Topics - May 12, 2008 Contents Latebreakers Letters R.Ph.s Say More Needs to be Done to Prevent Pediatric Drug Errors There's a New School of Thought on Use of Beta-Blockers for Hypertension Cover Story Guest Spot Letters Clinical Practice Special Report Professional Practice Broad Label for New Leukemia Therapy Looks Promising Treating Asthma During Pregnancy Safer than Not, Says New Guide In the Pipeline Clinical Q&A APhA Leader's Plan to Leave Office Takes Center Stage at its Conference Policies Passed at a Glance Giving a Talk to the Community? Check Out These Materials This Foundation has Funds to Spare JP at Large Cover Story: Employers and R.Ph.S: A Win-Win Combo FDA's Ilisa Bernstein Discusses Pharmacy Affairs Legal Q&A Manufacturers Unleash a Rash of Poison Ivy Treatments Are OTC Cold Remedies Safe for Kids? Probiotics are All the Rage: How You Can Capitalize on It CMS' Prices for Round One of DMEPOS Competitive Bidding Raising Concerns CVS Caremark's Mentoring Program Recruits and Retains R.Ph.s Antibiotic Resistance Among Community Pathogens Technology Update New Products Advertisers Index Classified Viewpoint

Drug Topics - May 12, 2008

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