Drug Topics - February 2009 - (Page 53)

Product Updates WHAT’S NEW cents 12 and older. For more information about Banzel, go to http://www. eisai.com/product.asp?ID=268. RX & OTC New Products 1 2 New Indication Schering-Plough announced the FDA has granted marketing approval to Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin, USP) combination therapy for use in previously untreated patients 3 years and older with chronic hepatitis C. This represents the ﬁrst and only approved combination of peginterferon and ribavirin for treating pediatric hepatitis C. See full US prescribing information and the medication guide for Pegintron at http://www. schering-plough.com. RX CARE New Drugs The Food and Drug Administration approved Abbott’s Trilipix (fenoﬁbric acid) [1], delayed-release capsules for use with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. Trilipix is the ﬁrst and only ﬁbrate to be approved for use in combination with a statin. Visit www.trilipix.com or call Abbott Medical Information at 800633-9110 for more information. The FDA has granted Pﬁzer’s Selzentry (maraviroc) full (traditional) approval for use in combination with other antiretrovirals in treatment-experienced adults with CCR5-tropic HIV-1. Selzentry now becomes the latest fully approved treatment for HIV. More information on the approved U.S. label is available at http:// www.selzentry.com. Akorn announced the FDA has granted approval for its ANDA for Ciproﬂoxacin HCl Ophthalmic Solution USP, 0.3%. This product is indicated for the treatment of infections caused by microorganisms in corneal ulcers and conjunctivitis. For additional information, go to http://www.akorn.com. Ligand Pharmaceuticals announced recently that the FDA has granted accelerated approval of GlaxoSmithKline’s Promacta (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufﬁcient response to corticosteroids, immunoglobulins, or splenectomy. For more product information, call 310-6917100 or e-mail dmarkley@lhai.com. Advertiser Index Eisai Corporation ASTEPRO Meda Pharmaceuticals of North America anCANCER CARE Ortho-Biotech nounced that the FDA CLARITIN Schering Plough has approved Banzel CORICIDIN Schering Plough (rufinamide) for the CORPORATE Actavis adjunctive treatment CORPORATE Fougera of seizures associated with Lennox-Gastaut CORPORATE Hamacher Resource Group syndrome (LGS) in CORPORATE Mylan Pharmaceuticals adults and children 4 CORPORATE QS / 1 years and older. Eisai CORPORATE Sagent received a complete CORPORATE ScriptPro response letter for CORPORATE Teamstaff RX Banzel’s use as an adEFFIENT B2B Eli Lilly & Company junctive treatment for FENTANYL Teva Pharmaceuticls USA partial-onset seizures MIRALAX Schering Plough with and without secSOMA 250 Meda Pharmaceuticals ondary generalization in adults and adolesTRILIPIX Abbott Laboratories VENLAFAXINE UCB Pharma Inc. ZOSYN Wyeth New Generics IMPAX Laboratories announced the FDA granted final approval of the company’s ANDA for a generic version of Wellbutrin XL 150 mg extended-release tablets. GlaxosmithKline markets Wellbutrin XL for the management of depression. Contact products@impaxlabs.com for information. Lannett announced that it has received approval from the FDA of its ANDA for Ursodiol 300 mg capsules, the generic equivalent of Actigall marketed by Watson Pharmaceuticals. Ursodiol is 9-10 54 39 25 31 5 26 CV4 59 HSE7 7 CV3 27 CV2,1,2 29 18-20,51-52 33-37 15-17 HSE3-5 53 DRUG TOPICS Februar y 2009 COURTESY OF ABBOTT (1), PROMIUS PHARMA (2) http://www.eisai.com/product.asp?ID=268 http://www.eisai.com/product.asp?ID=268 http://www.schering-plough.com http://www.schering-plough.com http://www.trilipix.com http://www.selzentry.com http://www.selzentry.com http://www.akorn.com

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Drug Topics - February 2009 Contents Health-System Edition Group Attempts to Resurrect Pain Care Act HSE Business Management HSE Clinical Letters Up Front Up Front in Depth Community Practice Niche Pharmacies Serve Special Populations Special Report Oral Oncology Drugs New Drugs Update 2008 Approvals OTC New Products Viewpoint

Drug Topics - February 2009

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