International Approvals

 
 
  • Tocilizumab Approved for Rheumatoid Arthritis in Europe The European Commission has approved Roche's first-in-class therapeutic tocilizumab for the treatment of moderate-to-severe rheumatoid arthritis. Efforts are underway to meet FDA requirements for US approval.
  • International Approvals: Januvia, Synvisc-One, Eloxatin Europe has approved 2 new indications for sitagliptin tablets (Januvia) and a new formulation of hylan G-F 20 (Synvisc-One); Canada has approved oxaliplatin intravenous infusion (Eloxatin).
  • International Approvals: Humira, Atripla, Januvia Europe has approved a new indication for adalimumab subcutaneous injection (Humira) and efavirenz/emtricitabine/tenofovir disoproxil fumarate combination tablets (Atripla); Canada has approved sitagliptin phosphate tablets (Januvia).
  • International Approvals: Isentress, Rexin-G, Vectibix Europe has approved raltegravir tablets (Isentress); the Philippines has approved a tumor-targeted gene delivery product (Rexin-G); and Europe has approved panitumumab intravenous infusion (Vectibix).
  • International Approvals: Isentress, WinRho SDF, Cyanokit Canada has approved raltegravir tablets (Isentress) and a liquid formulation of a Rho (D) intravenous immune globulin [human] product (WinRho SDF); Europe has approved a hydroxocobalamin kit (Cyanokit).
  • International Approvals: Tasigna, Eraxis, INOmax Europe has approved nilotinib capsules (Tasigna), Canada has approved anidulafungin intravenous infusion (Eraxis), and Australia has approved nitric oxide for inhalation (INOmax).
  • International Approvals: Torisel, Rocephin, Sigmart Europe has approved temsirolimus injection (Torisel); Japan has approved a new dosing regimen for ceftriaxone injection (Rocephin) and an expanded indication for nicorandil injection (Sigmart).
  • International Approvals: Oral-lyn, Abraxane, DepoDur India has approved a regular insulin oral spray (Oral-lyn) and albumin-bound paclitaxel particles for injectable suspension (Abraxane); Australia has approved a sustained-release liposome formulation of morphine sulfate injection (DepoDur).
  • International Approvals: Nexavar, Elaprase, Aranesp Europe has approved a new indication for sorafenib tosylate tablets (Nexavar) and an expanded indication for darbepoetin alfa (Aranesp); Japan has approved idursulfase solution (Elaprase).
  • International Approvals: Levemir, Plavix, Celsentri Japan has approved insulin detemir injection (Levemir) and a new indication for clopidogrel tablets (Plavix); Canada has approved maraviroc tablets (Celsentri).
  • International Approvals: Atripla, Cubicin, Galvus Canada has approved efavirenz/emtricitabine/tenofovir disoproxil fumarate tablets (Atripla) and daptomycin intravenous infusion (Cubicin); Europe has approved vildagliptin tablets (Galvus).
  • International Approvals: Exelon, Aclasta, Celsentri Europe has approved a new indication for a rivastigmine transdermal system (Exelon Patch), a new indication for zoledronic acid 5-mg injection (Aclasta), and maraviroc 150- and 300-mg tablets (Celsentri).
  • International Approvals: Tamiflu, Seroquel XR, Rebif Europe has approved pediatric dose strengths of oseltamivir phosphate capsules (Tamiflu), the Netherlands has approved quetiapine fumarate extended-release tablets (Seroquel XR), and Europe has approved a new formulation of interferon beta-1a injection (Rebif).
  • International Approvals: NovoRapid, Fentanyl, Atriance Europe has approved an expanded indication for insulin aspart subcutaneous injection (NovoRapid), Japan has approved an expanded indication for fentanyl citrate 0.1 and 0.25 mg injections, and Europe has approved nelarabine intravenous injection (Atriance).
  • International Approvals: Cubicin, BeneFIX, Aricept Europe has approved 2 new indications for daptomycin intravenous infusion (Cubicin) and enhancements for recombinant coagulation factor IX intravenous injection (BeneFIX); Japan has approved a new dose and indication for donepezil HCl tablets (Aricept).
  • International Approvals: Ralivia, Rasilez, Avastin Canada has approved a once-daily, extended-release formulation of tramadol HCl tablets (Ralivia); Europe has approved aliskirin tablets (Rasilez) and a new indication for bevacizumab infusion (Avastin).
  • International Approvals: Actonel, Alvesco, Increlex Canada has approved a new tablet strength and related regimen for risedronate sodium tablets (Actonel) and an expanded indication for inhaled ciclesonide (Alvesco); Europe has approved mecasermin [rDNA origin] 10-mg/mL injection (Increlex).
  • International Approvals: Sativex, Travatan Z, Eslax Canada has approved a new indication for a cannabis-derived buccal spray (Sativex); Japan has approved travoprost 0.004% ophthalmic solution (Travatan Z) and rocuronium bromide injection (Eslax).
  • International Approvals: Prexige, Elaprase, Micera Canada has approved an expanded indication for lumiracoxib tablets (Prexige) and idursulfase 2-mg/mL solution (Elaprase); Europe has approved a continuous erythropoietin receptor activator (Micera).
  • International Approvals: Seasonale, Pergoveris, Tambocor Canada has approved an extended-cycle birth control regimen (Seasonale), Europe has approved a fertility biotechnology product (Pergoveris), and Japan has approved a new indication for flecainide (Tambocor).