Drug news
Orexigen files Contrave for Obesity in the EU
Orexigen has submitted the Marketing Authorization Application for Contrave (naltrexone HCl/bupropion) to the European Medicines Agency. It is seeking approval for Contrave (32 mg naltrexone sustained release (SR) / 360 mg bupropion SR) for the management of Obesity, including weight loss and maintenance of weight loss, in conjunction with lifestyle modification. Orexigen also plans to resubmit its NDA before the end of 2013 to the FDA, after delays following a 2012 request from the FDA for a cardiovascular outcomes trial with the drug.