Drug Topics - February 11, 2008 - (Page 60) 60 DRUG TOPICS FEBRUARY 11, 2008 www.drugtopics.com > > > New Products Rx NEW DRUGS The FDA has approved Voluven, manufactured by German company Fresenius Kabi, www.fresenius-kabi.com. The new intravenous product contains 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection and is indicated for restoring blood volume following surgery. The synthetic starch molecules contained in the product do not dissolve in water and are linked together and combined with a salt solution in a concentration similar to human blood. The drug is not indicated for patients on dialysis or with kidney failure, bleeding inside the head, severe increases in blood levels of sodium chloride, or known sensitivity to the synthetic starch in the drug. NEW INDICATIONS Tysabri (natalizumab), a biologic medication from Elan and Biogen, www.tysabri.com, has been approved for the treatment of Crohn’s disease. The drug is indicated for inducing and maintaining clinical response and remission in adult patients with active Crohn’s Disease with evidence of inflammation who have not had success with traditional Crohn’s disease therapies. Tysbari was previously approved for relapsing forms of multiple sclerosis. NEW DOSAGE The FDA has approved a new once-daily dosage for Eli Lilly’s blockbuster erectile dysfunction drug Cialis (tadalafil), www.cialis.com. The new dosages will come in 2.5-mg and 5-mg forms. Men taking the medication will be able to attempt sexual activity anytime in between dosages. Previously Cialis had been approved for patients to take as needed with dosages ranging between 5mg and 20mg. CSL Behring, www.cslbehring.com, has begun offering Helixate FS, its advanced recombinant FVIII (rFVIII) factor product for the treatment of hemophilia A, in a 2000IU vial. According to the company, the new vial size offers shorter infusion time and is packaged with Mix2Vial, its needle-free transfer device. Glumetza (metformin hydrochloride extendedrelease tablet) is now available from Depomed, www.glumetzaxr.com, in a 1000-mg tablet. It offers once-daily oral dosing for adults with Type 2 diabetes. The tablets, manufactured by King, utilize Depomed’s AcuForm drug delivery technology to provide controlled and prolonged release of metformin. The drug is indicated for use alone or in combination with sulfonylurea or insulin as an adjunct to diet and exercise for improved glycemic control. Shire USA has received approval to offer three new dosage strengths for its attention deficit hyperactivity disorder (ADHD) drug Vyvanse (lisdexamfetamine dimesylate). Vyvanse, www.vyvanse.com, is therapeutically inactive until metabolized in the body and will now be available in 20-, 40-, and 60mg dosage strengths for once-daily dos- ADVERTISERS INDEX ABREVA (GlaxoSmithKline Consumer HealthCare) . . . . 27 ACTOS (Takeda Pharmaceuticals) . . . . . . . . . INSERT, 61 AMITIZA (Takeda Pharmaceuticals) . . . . 23, INSERT, 29 BYSTOLIC (Forest Laboratories) . . . . . . . . . . . . . . INSERT CORICIDIN (Schering-Plough HealthCare) . . . . . . . . . . . 35 CORPORATE (EPS, Inc.) . . . . . . . . . . . . . . . . . . . . . . . . HSE3 CORPORATE (McKesson) . . . . . . . . . . . . . . . . . . . . . . . . . 67 CORPORATE (Mylan Pharmaceuticals) . . . . . . . . . . . . . BC CORPORATE (Office of National Drug Control Policy) . . . . . . . . . . . . . . . 44 CORPORATE (Parata) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 CORPORATE (QS/ 1 Data Systems) . . . . . . . . . . . . . . . . . 59 CORPORATE (SCRIPTPRO) . . . . . . . . . . . . . . . . . . . . . . . . 31 CUBICIN (Cubist Pharmaceuticals) . . . . . . . . . . . . HSE5-6 FAMCICLOVIR TABLETS (Teva Pharmaceuticals USA) . . . . . . . . . . . . . . . . . . . . . . . . IFC FLEXPEN (Novo Nordisk) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 FLUARIX (GlaxoSmithKline ConsumerHealthCare) . . . . . . . . . . . . . . . . . . . . . . . . . INSERT HALFLYTELY (Braintree Laboratories) . . . . . . . . . . . 63-64 HUMALOG (Eli Lilly and Co.) . . . . . . . . . . . . . . . . . . . . 18-21 LEXAPRO (Forest Laboratories) . . . . . . . . . . . . INSERT,13 METOPROLOL SUCCINATE (Ethex Corp.) . . . . . . . . . 43 MOMETASONE FUROATE (Fougera) . . . . . . . . . . . . . . . 3 MUCINEX (Adams Respiratory Therapeutics) . . . . . . . . 11 NEUPRO (UCB, Inc.) . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-16 OPTIVE (Allergan, Inc.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 PDR (Thomson) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 PRILOSEC OTC (Procter & Gamble) . . . . . . . . . . . . . . . . 39 SELZENTRY (Pfizer Labs) . . . . . . . . . . . . . . . . INSERT, 25 TYGACIL (Wyeth Pharmaceuticals) . . . . . . . . . . . HSE9-10 ULTRAMINI (LifeScan, Inc.) . . . . . . . . . . . . . . . . . . . . . . . . . 7 ZOSYN (Wyeth Pharmaceuticals) . . . . . . . . . . . HSE 13-15 ZYRTEC (McNeil-PPC) . . . . . . . . . . . . . . . . . . . . . . . . . . . IBC IFC-Inside front cover IBC-Inside back cover BC-Back cover http://www.drugtopics.com http://www.fresenius-kabi.com http://www.tysabri.com http://www.cialis.com http://www.cslbehring.com http://www.glumetzaxr.com http://www.vyvanse.com http://www.vyvanse.com
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