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Orexigen's Mysimba(TM) (Naltrexone HCl / Bupropion HCl Prolonged Release) Receives Positive CHMP Opinion Recommending Approval For Weight Management In The European Union *
Friday 12/19/2014 07:20 AM ET - Dow Jones News
Orexigen's Mysimba(TM) (naltrexone HCl / bupropion HCl prolonged release) Receives Positive CHMP Opinion Recommending Approval for Weight Management in the European Union
Friday 12/19/2014 07:20 AM ET - PR Newswire via Dow Jones News
LA JOLLA, Calif., Dec. 19, 2014 /PRNewswire/ -- Orexigen Therapeutics (NASDAQ: OREX) announced today that the Committee for Medicinal Products For Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a centralized marketing authorization for Mysimba(TM) (naltrexone HCI / bupropion HCI prolonged release), as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (>=18 years) with an initial Body Mass Index (BMI) of >= 30 kg/m(2) (obese), or >= 27 kg/m(2) to 30 kg/m(2) (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension).
EMA: Positive Recommendation On Xiapex By Swedish Orphan Biovitrum *
Friday 12/19/2014 07:19 AM ET - Foreign Wire via Dow Jones News
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