International Approvals

 
 
  • International Approvals: Tasigna, Once-Daily Tramadol, Hexvix Switzerland has approved nilotinib (Tasigna), Canada has approved a once-daily formulation of tramadol HCl, and Italy has granted marketing authorization for a hexaminolevulinate product (Hexvix).
  • International Approvals: Yaz, Soliris, Glucomed/Flexove The Netherlands has approved a 24-day active-hormone regimen of drospirenone/ethinyl estradiol tablets (Yaz); Europe has approved eculizumab injection (Soliris); and marketing approval for a glucosamine HCl product (Glucomed tablets) has been granted in France and the United Kingdom.
  • International Approvals: DCVax-Brain, PegIntron/Rebetol, Revlimid Switzerland has approved a therapeutic vaccine (DCVax-Brain); the EU has improved an expanded indication for combination therapy with peginterferon alfa-2b (PegIntron) and ribavirin (Rebetol), and lenalidomide capsules (Revlimid).
  • International Approvals: Tysabri, Elaprase, Invega The United Kingdom has approved natalizumab intravenous infusion (Tysabri), Health Canada has approved idursulfase intravenous infusion (Elaprase), and the EU has approved paliperidone prolonged-release tablets (Invega).
  • International Approvals: Mycamine, Tracleer, Thalidomide Canada has approved micafungin sodium injection (Mycamine), the EU has approved a new indication for bosentan tablets (Tracleer), and France has expanded its temporary authorization for use of thalidomide.
  • International Approvals: NuvaRing, Remicade, Plavix An etonogestrel/ethinyl estradiol vaginal ring (NuvaRing) has been approved in 13 additional European countries; Europe has approved a new indication for infliximab injection (Remicade), and Canada has approved a new indication for clopidogrel bisulfate tablets (Plavix).
  • International Approvals: Optaflu, Altabax, Laresse The EU has approved an influenza vaccine (Optaflu) and retapamulin 1% ointment (Altabax); Australia has approved a temporary dermal filler (Laresse).
  • International Approvals: Thelin, VIG, PDX Canada has approved sitaxentan sodium tablets (Thelin) and vaccinia immune globulin injection (VIG); the EU has granted orphan drug status for pralatrexate injection (PDX).
  • International Approvals: Cervarix, Accomplia, Orencia Australia has approved a cervical cancer vaccine (Cervarix), Brazil has approved rimonabant tablets (Accomplia), and the EU has approved abatacept injection (Orencia).
  • Approvals: Herceptin, Reyataz, and Peg-Intron Europe has approved a new indication for trastuzumab infusion (Herceptin), Canada has approved a 300 mg capsule formulation for atazanavir sulfate (Reyataz), and China has approved a new indication for peginterferon alfa-2b injection (Peg-Intron).
  • International Approvals: Aerius, Sebivo, Rapydan Europe has approved desloratadine orodispersible tablets and oral solution (Aerius) and telbivudine 600-mg tablets (Sebivo); Sweden has approved a lidocaine/tetracaine 70-mg/70-mg local anesthetic patch (Rapydan)
  • International Approvals: Lipitor, Requip LP, Avastin Canada has approved an expanded indication for atorvastatin calcium tablets (Lipitor), France has approved ropinirole HCl prolonged release tablets (Requip LP), and Japan has approved bevacizumab intravenous infusion (Avastin).
  • International Approvals: FulFil, TriActiv ProGuard, Elevess The EU has approved a saline-filled facial implant (FulFil), an expanded indication for a third-generation embolic protection system (TriActiv ProGuard), and an injectable dermal filler (Elevess).
  • International Approvals: Remicade, Fodosine, Sprycel The EU has approved a label extension for infliximab injection (Remicade) and orphan drug status for fodosine (Fodosine); Canada has approved dasatinib tablets (Sprycel).
  • International Approvals: Januvia, Avastin, Xeloda The EU has approved sitagliptin tablets (Januvia) and new indications for bevacizumab injection (Avastin) and capecitabine tablets (Xeloda).
  • International Approvals: Symbicort SMART, Alimta, Xyrem Canada has approved budesonide plus formoterol fumarate dehydrate inhalation aerosol (Symbicort SMART) and a new indication for indication for pemetrexed injection (Alimta); the EU has approved a new indication for sodium oxybate oral solution (Xyrem).
  • International Approvals: Pariet, Fludara Oral, Sandoglobulin NF Liquid Japan has approved a new indication for rabeprazole sodium 10-mg tablets (Pariet) and an oral formulation of fludarabine (Fludara Oral); Canada has approved a ready-to-use formulation for immunoglobulin [human] intravenous injection (Sandoglobulin NF Liquid).
  • International Approvals: Prezista and Kogenate Bayer The EU has granted conditional approval for darunavir ethanolate 300-mg tablets (Prezista), and the agency has approved an expanded regimen for antihemophilic factor VIII [recombinant, formulated with sucrose] injection (Kogenate Bayer).
  • International Approvals: Taxotere, Copegus, Inovelon Canada has approved a new indication for docetaxel injection (Taxotere), Japan has approved ribavirin tablets (Copegus), and the EU has approved rufinamide tablets (Inovelon).
  • International Approvals: Mirena, Champix, Elaprase Japan has approved a long-acting intrauterine contraceptive system (Mirena), Canada has approved varenicline tartrate tablets (Champix), and the EU has approved idursulfase intravenous infusion (Elaprase).