Drug Topics - October 8, 2007 - (Page 50)

50 DRUG TOPICS OCTOBER 8, 2007 www.drugtopics.com > > > New Products Rx NEW DRUGS A new prescription drug product is now available for the treatment of seborrheic dermatitis and tinea versicolor of the skin. Tersi Foam, from Quinnova Pharmaceuticals, Newtown, Pa., contains 2.25% selenium sulfide as its active ingredient. It provides a leave-on foam to help reduce the Malassezia fungi that compromise a patient’s natural skin barrier, resulting in inflammation, flaking, and redness. Quinnova can be reached at (215) 860-6263. Swiss firm TopoTarget A/S, with U.S. offices in Rockaway, N.J., (973) 895-6900, has received FDA approval for Totect (dexrazoxane for injection). The IV drug is indicated for the treatment of extravasation resulting from IV anthracycline chemotherapy. French firm Ipsen, through its partner Tercica, Brisbane, Calif., (650) 624-4900, is making available new FDA-approved Somatuline Depot (lanreotide) Injection—60, 90, and 120 mg/mL—in the United States. The product is indicated for the long-term treatment of acromegaly in patients who have responded inadequately to surgery and/or radiotherapy, or for whom those treatments are not an option. Acambis plc, Cambridge, Mass., (617) 761-4200, has FDA approval for ACAM2000 (smallpox [vaccinia] vaccine, live) Vaccine for active immunization against smallpox in persons at high risk for the infection. The approval also looks ahead to use as preparedness against the threat of smallpox. This single-dose vaccine is the primary agent in the government stockpile for use in an emergency. A.T.S. Pharmaceuticals, Los Angeles, (866) 2874428, a division of Auriga Laboratories, is launching Xyralid Cream (lidocaine HCl 3%/hydrocortisone acetate 1%), a kit that also contains Cleré, a soap-free cleanser. This is the third product in the Xyralid line, which also includes Xyralid RC and Xyralid LP Lotion. The new kit is indicated for antiinflammatory anesthetic relief of pruritus—including pruritic eczemas, abrasions, minor burns, insect bites, and other conditions of the skin and mucous membranes. NEW LABELING The FDA has approved updated prescribing information for Coumadin (warfarin sodium), a bloodthinning agent from Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000. The labeling will explain that people’s genetic makeup may influence their response to the drug. It is hoped that healthcare providers can use genetic tests to more accurately prescribe warfarin dosing for individual patients in order to lower the risk of bleeding complications. MGI Pharma, Minneapolis, (952) 346-4700, has been granted a labeling change for Aloxi (palonosetron hydrochloride) Injection. Following results from several safety and efficacy trials evaluating multiple-day dosing of the agent, the label change permits the removal of a dosing recommendation that limited use of the product to once in every seven-day interval. Palonosetron hydrochloride is approved for prevention of the acute nausea and vomiting of initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. MedImmune Inc., Gaithersburg, Md., (301) 398-0000, has gained FDA approval for the expanded use of Flumist (influenza virus vaccine live, intranasal) in children two to five years of age. The product was already approved ADVERTISERS INDEX ACTOS (Takeda Pharmaceuticals) INSERT, 25 ALLI (GlaxoSmithKline) 15 CARVEDILOL (GlaxoSmithKline) 51 CORPORATE (Customer Link) 32 CORPORATE (Innovia Medical) 33 CORPORATE (McKesson) 27 CORPORATE (Mylan Pharmaceuticals) 5 CORPORATE (QS/1) 23 CORPORATE (ScriptPro) 36 CORPORATE (Target) 47 COUGH/COLD (Adams Respiratory Therapeutics) 7 FLEXPEN (Novo Nordisk) 29 FREESTYLE LITE (Abbott Laboratories) 31 LEXAPRO (Forest Laboratories) INSERT, 17 LOVAZA (Reliant Pharmaceuticals) 19-20 MICROELITE (Respironics) 49 NEUPRO (Schwarz Pharma) 9-12 NOVOLOG MIX (Novo Nordisk) IBC, BC PRONTO (Del Laboratories) 35 SULFACETAMIDE SODIUM (Fougera) 3 ZICAM (Matrixx Initiatives) IFC IFC-Inside front cover IBC-Inside back cover BC-Back cover http://www.drugtopics.com

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Drug Topics - October 8, 2007 Latebreakers Latebreakers in Depth Letters Rx Care Community Practice JP at Large 150 Years of American Pharmacy Hospital Practice Are You Getting Pharmacy's Message Across? Self-Care Government and Law Legal Q&A The Pharmacist as First Responder in Disaster Relief Technology Update New Products Advertisers Index Statement of Ownership Classified Viewpoint

Drug Topics - October 8, 2007

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