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After refusing two of obesity drug candidates in recent months, the FDA Endocrinologic and Metabolic Advisory Committee recommended that the drug two weeks ago that the agency approves third drug, Contrave (naltrexone sustained release [SR] / bupropion SR) at Orexigen therapy (San Diego). Panel members voted to approve the drug 07/13, but it is recommended that additional studies are conducted to investigate the potential risks of heart. If the FDA approves Contrave, he will become the first new prescription weight-loss treatment to more than ten years. Agencies, which are not required to follow the advice of its expert panels but usually does is to take a decision on the status of the drug on 31 January 2011.This week, FDA staff met with the heads of Arena Pharmaceuticals (San Francisco), the developer rejected lorcaserin obesity drugs, and identified plan for the company to upgrade its new drug application and seek future approval. Arena's President and Chief Executive Officer Jack Leaf said in a statement that the company expects to refile NGOs by the end of 2011.In September lorcaserin was rejected in 5.9 votes on the panel because of concerns that early testing showed mammary tumors in rats . In October, Arena said in a press statement that a complete response letter to FDA (CRL) said concerns about cancer risks, as well as the effectiveness of the drug, saying that the weight loss experienced by people without type 2 diabetes in clinical trials was low. Qnexa (phentermine / topiramate) by Vivus (Mountain View, Calif.) was also rejected (vote 10-6) Committee of the FDA in July due to health risks, in particular, concern about cardiovascular diseases and birth defects. Vivus said last week that he submitted an information document for the FDA to address its establishment in the CRL, and also meet with endocrine and metabolic division of the FDA in January to discuss the re-possibilities.On Monday, Vivus has started the approval process in Europe Qnexa filing for marketing authorization with the European Medicines Agency. The company said the drug could be approved at the end of next year.See articles PharmTech: security issues requested by the FDA denial of Qnexa and "No" LorcaserinFDA Panel Votes to fight obesity Arena DrugFDA still mulling Obesity DrugsThe FDA Panel also stated that Contrave not provide sufficient evidence that the drug was safe for the heart. Panel vote of 11 to 8 that further studies should be presented (in testing for the elderly) that the drug Wil does not cause heart problems. This is promising a positive step, but the jury is still out on safety Contrave Trackback URI | Subscribe to the comments via RSS Feed name (required) Email (will not be shown) (required) Website XHTML: You can use these tags: <a href = "" title = ""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <Em> <i> <Q cite = ""> <strike> <strong> Copyright В© 2011 PharmTech Talk WordPress Theme based on light theme
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Moms-to-be need for early warning of diabetes - National

Moms-to-be need for early warning of diabetes - National
Moms-to-be need for early warning of diabetes - National

Moms-to-be need for early warning of diabetes - National
Moms-to-be need for early warning of diabetes - National

Respiratory drugs increases the risk of diabetes - MedPage Today

Moms-to-be need for early warning of diabetes - National
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Moms-to-be need for early warning of diabetes - National
How to think about the treatment of diabetes mellitus: Part 2 - AOL Health
USV looks monetization of U.S. patent for a kidney drug - istockAnalyst.com (press release)
Respiratory drugs increases the risk of diabetes - MedPage Today
Moms-to-be need for early warning of diabetes - National
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How to think about the treatment of diabetes mellitus: Part 2 - AOL Health
Moms-to-be need for early warning of diabetes - National

FDA Approves PREZISTA В® / ritonavir once daily for HIV-1 treatment ... - SYS-CON Media (press release)
comparison of glargine and oral antidiabetic drugs
comparison of glargine and oral antidiabetic drugs
How to think about the treatment of diabetes mellitus: Part 2 - AOL Health

Respiratory drugs increases the risk of diabetes - MedPage Today
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Afrezza MannKind has a mega-blockbuster potential - Seeking Alpha
How to think about the treatment of diabetes mellitus: Part 2 - AOL Health
Moms-to-be need for early warning of diabetes - National
Afrezza MannKind has a mega-blockbuster potential - Seeking Alpha
How to think about the treatment of diabetes mellitus: Part 2 - AOL Health
Standard cards allergy planned - Malaysia Star
FDA Approves PREZISTA В® / ritonavir once daily for HIV-1 treatment ... - SYS-CON Media (press release)

How to think about the treatment of diabetes mellitus: Part 2 - AOL Health
Afrezza MannKind has a mega-blockbuster potential - Seeking Alpha
Moms-to-be need for early warning of diabetes - National
USV looks monetization of U.S. patent for a kidney drug - istockAnalyst.com (press release)
FDA Approves PREZISTA В® / ritonavir once daily for HIV-1 treatment ... - SYS-CON Media (press release)
Moms-to-be need for early warning of diabetes - National
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Surprise teacher works to raise money for diabetes fight - Ahwatukee Foothills News
Surprise teacher works to raise money for diabetes fight - Ahwatukee Foothills News
Position Statement advocates physical activity for patients with type 2 diabetes - Endocrine Today
Surprise teacher works to raise money for diabetes fight - Ahwatukee Foothills News

USV looks monetization of U.S. patent for a kidney drug - istockAnalyst.com (press release)
Moms-to-be need for early warning of diabetes - National
Moms-to-be need for early warning of diabetes - National
Respiratory drugs increases the risk of diabetes - MedPage Today
How to think about the treatment of diabetes mellitus: Part 2 - AOL Health
Moms-to-be need for early warning of diabetes - National
FDA Approves PREZISTA В® / ritonavir once daily for HIV-1 treatment ... - SYS-CON Media (press release)
photohemolysis due to oral antidiabetic drugs
Position Statement advocates physical activity for patients with type 2 diabetes - Endocrine Today
Surprise teacher works to raise money for diabetes fight - Ahwatukee Foothills News