International Approvals

International Approvals: Exforge, HepaGam B, Sutent The EU has approved valsartan plus amlodipine besylate tablets (Exforge) and a new indication for sunitinib malate capsules (Sutent); Canada has approved hepatitis B immune globulin [human] injection (HepaGam B).
News, January 27, 2007
International Approvals: Cipralex, Neupro, Relenza The EU has approved a new indication for escitalopram oxalate (Cipralex) and an expanded indication for rotigotine transdermal patch (Neupro); Canada has approved a new indication for inhalable zanamivir (Relenza with Diskhaler).
News, January 23, 2007
International Approvals: Keppra, NeoRecormon, Wellbutrin XR The EU has approved new indications for levetiracetam (Keppra) and epoetin beta 30,000 IU injection (NeoRecormon); the Netherlands has approved bupropion HCl 150- and 300-mg modified-release tablets (Wellbutrin XR).
News, January 19, 2007
International Approvals: Hyzaar, Glucomed/Flexove, Diacol Canada has approved an expanded indication for losartan potassium plus hydrochlorothiazide (Hyzaar and Hyzaar DS); the EU has granted final approval for a glucosamine HCl product (Glucomed/Flexove tablets); and the United Kingdom has approved sodium phosphate tablets (Diacol).
News, December 19, 2006
International Approvals: Humira Pen, Dynamic Cervical Implant, Arctic Sun Canada has approved a device (Humira Pen) to administer an arthritis drug; the EU has approved a titanium implant (Dynamic Cervical Implant), and Japan has approved a temperature management system (Arctic Sun).
News, December 12, 2006
International Approvals: Solaraze, Nasonex, Advate Australia has approved diclofenac sodium 3% gel (Solaraze), Canada has approved a new indication for mometasone furoate monohydrate nasal spray (Nasonex), and Japan has approved rurioctocog alfa [recombinant, plasma/albumin-free method: rAHF-PFM] infusion (Advate).
News, December 05, 2006
International Approvals: Byetta and Noxafil The EU has approved exenatide injection (Byetta) and a new indication for posaconazole 40-mg/mL oral suspension (Noxafil).
News, November 28, 2006
International Approvals: Accomplia and Noxafil Mexico has approved rimonabant tablets (Accomplia), and the EU has approved a new indication for posaconazole oral suspension (Noxafil).
News, November 20, 2006
International Approvals: Gen-Probe PCA3, OPTTX, WalkAide The EU has approved a gene-based urine test (Gen-Probe PCA3), an angiogram and laser treatment device (OPTTX), and a functional electrical stimulation device (WalkAide).
News, November 14, 2006
International Approvals: Prexige, Femara, and Vasovist Europe has approved lumiracoxib 100-mg tablets (Prexige); Canada has approved a new indication for letrozole tablets (Femara) and gadofosveset trisodium injection (Vasovist).
News, November 10, 2006
International Approvals: Zenith Branch, Promus, Endeavor The EU has approved an endovascular graft (Zenith Branch), and the EU and Australia have approved everolimus- and zotarolimus-eluting coronary cobalt-chromium stent systems, respectively (Promus and Endeavor).
News, November 07, 2006
International Approvals: Suboxone, Replagal, Sonazoid The EU has approved buprenorphine HCl plus naloxone HCl sublingual tablets (Suboxone) and an expanded indication for agalsidase alfa injection (Replagal); Japan has approved perflubutane injection (Sonazoid).
News, November 06, 2006
International Approvals: Coversyl, Exjade, and Loramyc Canada has approved a new indication for perindopril erbumine 2-, 4-, and 8-mg tablets (Coversyl); the EU has approved deferasirox tablets for oral suspension (Exjade); and France has approved miconazole Lauriad 50-mg bioadhesive buccal tablets (Loramyc).
News, October 27, 2006
International Approvals: Sebivo and Tysabri Switzerland has approved telbivudine tablets (Sebivo), and Canada has approved natalizumab injection (Tysabri).
News, October 23, 2006
International Approvals: Lyrica and Remicade The EU has approved expanded indications for pregabalin capsules (Lyrica) and infliximab injection (Remicade).
News, October 16, 2006
International Approvals: Champix, Synvisc, Glivec The EU has approved varenicline tartrate 0.5- and 1-mg tablets (Champix), an expanded indication for hylan G-F 20 injection (Synvisc), and new indications for imatinib mesylate tablets (Glivec).
News, October 09, 2006
International Approvals: Melody/Ensemble, Organ Care System, Eon The EU has approved a transcatheter pulmonary valve (Melody) with delivery system (Ensemble), and a maintenance system for donor organs (Organ Care System); Australia has approved an implantable pulse generator neurostimulation system (Eon).
News, October 06, 2006
International Approvals: Singulair and Gardasil/Silgard Canada has approved a new indication for montelukast sodium (Singulair), and Europe has approved a quadrivalent recombinant vaccine (Gardasil/Silgard).
News, October 02, 2006
International Approvals: Foster, Keppra, ATryn Germany has approved a formoterol plus beclomethasone dipropionate hydrofluoroalkane-propelled inhaler (Foster); the EU has approved a new indication for levetiracetam (Keppra), and a transgenically-produced recombinant form of human antithrombin for infusion (ATryn).
News, September 25, 2006
International Approvals: Alvesco, Plavix, Paromomycin Injection Canada has approved the inhaled corticosteroid ciclesonide (Alvesco); the EU has approved a new indication for clopidogrel bisulfate (Plavix); and India has approved paromomycin intramuscular injection.
News, September 18, 2006

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