sanofi-aventis has decided to withdraw the New Drug Application for rimonabant in the US
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■ sanofi-aventis has decided to withdraw the New Drug Application for rimonabant in the US, according to a company media release,1 but plans to submit the rimonabant file to the US FDA in the future, and will enter into discussions with the FDA in order to determine required modifications to the file. In June this year, following a meeting convened because of concerns about the drug’s adverse event profile, particularly adverse psychiatric reactions,2 the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee did not recommend that the FDA approve Zimulti [rimonabant] for the treatment of obese or overweight patients with associated risk factors.3 1. sanofi-aventis. Rimonabant Regulatory Update in the United States. Media Release : 29 Jun 2007. Available from: URL: http://www.sanofi-aventis.us. 2. FDA. Memorandum - Advisory Committee meeting for rimonabant (Zimulti TM). Company Communication : [3 pages], 13 Jun 2007. 3. sanofi-aventis. FDA Advisory Committee Did Not Recommend Approval of Rimonabant (ZIMULTI(R)) for Use in Obese and Overweight Patients With Associated Risks Factors. Media Release : 13 Jun 2007. Available from: URL: http://www.sanofi-aventis.us. 801052192
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Reactions 7 Jul 2007 No. 1159
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