International Approvals

Europe Okays Pneumonia Vaccine for Adults 50 Years and Older Pfizer's Prevenar 13 is the first and only pneumococcal conjugate vaccine approved for use in adults in the European Union.
News, October 28, 2011
Pemetrexed Approved in EU for NCSLC Continuation Maintenance This is the first chemotherapy approved in the European Union (EU) for continuation maintenance therapy in advanced nonsquamous nonsmall-cell lung cancer (NSCLC).
News, October 28, 2011
European Nod for HG Nerve Stimulation in Sleep Apnea Implantable device for hypoglossal nerve stimulation improves sleep apnea and quality of sleep, life, and health.
News, October 27, 2011
Linagliptin Approved in Canada for Type 2 Diabetes Linagliptin is the first dipeptidyl peptidase-4 (DPP-4) inhibitor that does not require dose adjustment for patients with mild to moderate renal impairment.
News, October 04, 2011
Telaprevir Receives European Approval The hepatitis C drug, marketed under the brand name Incivek in the United States, will be sold as Incivo throughout the European Union.
News, September 21, 2011
Europe Approves Telavancin for Hospital-Acquired Pneumonia Clinical study data suggest telavancin's clinical efficacy is comparable to that of vancomycin.
News, September 19, 2011
Health Canada Approves Everolimus for Pediatric Brain Tumors Everolimus is for the treatment of tumors caused by tuberous sclerosis complex.
News, September 14, 2011
Precision Laser System Approved for Cataract Surgery in Europe A new image guidance system automatically detects lens and corneal surfaces for safe and accurate laser delivery.
News, September 12, 2011
Abiraterone for Prostate Cancer Now Approved in Europe Experts welcome the new drug because men with castration-resistant prostate cancer that has progressed on chemotherapy have few options.
News, September 08, 2011
Neurostimulation Gets CE Mark Approval for Chronic Migraine European CE Mark approval has been granted for implanted neurostimulation system to treat intractable chronic migraines.
News, September 07, 2011
Denosumab Approved in EU for Cancer With Bone Metastases The novel bone agent denosumab has been approved in all 27 member states of the European Union for use in adult patients with solid tumors and bone metastases.
News, July 19, 2011
European Union Approves Nilotinib First-Line Therapy for Ph+ CML The European Commission has approved nilotinib for the first-line treatment of chronic-phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in adults.
News, January 03, 2011
Russia Approves Oral Cladribine to Treat MS The Russian Federal Service on Surveillance in Healthcare and Social Development has approved an oral formulation of cladribine for the treatment of relapsing-remitting MS.
News, July 22, 2010
Roflumilast Approved in Europe for Chronic Obstructive Pulmonary Disease The EC has approved roflumilast once-daily tablets as an add-on to bronchodilator therapy for the maintenance treatment of severe COPD associated with chronic bronchitis in adults.
News, July 21, 2010
EC Approves 3-Month Treatment Period for Melatonin Sleep Product The EC has approved a change in treatment duration from 3 to 13 weeks for a prolonged-release melatonin product used to combat primary insomnia in patients aged 55 years and older.
News, July 08, 2010
Filgrastim Approved in EU to Prevent Febrile Neutropenia Linked With Chemotherapy The European Commission has approved a biosimilar formulation for filgrastim to prevent febrile neutropenia and reduce the duration of chemotherapy-induced neutropenia.
News, June 17, 2010
Health Canada Approves Trabectedin for Relapsed Ovarian Cancer Addition of trabectedin to pegylated liposomal doxorubicin may increase progression-free survival.
News, May 26, 2010
Health Canada Approves Darunavir for Pediatric Use Health Canada has approved darunavir with ritonavir and other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients aged 6 to 18 years.
News, February 11, 2010
Trastuzumab Approved for HER2 Gastric Cancer in Europe This is the first approval for a label extension for trastuzumab, which is already marketed for the treatment of HER2-positive breast cancer.
News, February 02, 2010
EU Approves First Long-Acting Fertility Treatment The European Commission has approved corifollitropin alfa subcutaneous injection, the first sustained follicle stimulant.
News, February 02, 2010

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