Meeting Materials NOW Available! – Tasimelteon Capsules

Posted by on November 12, 2013

November 14, 2013 8:00 a.m. to 5:00 p.m.: Peripheral and Central Nervous System Drugs Advisory Committee Meeting
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FREE Quarterly Giveaway – Guide to the FDA’s White Oak Campus

Posted by on November 5, 2013

Planning a meeting at the FDA White Oak Campus? Download our multi-page Guide to FDA White Oak now and be prepared!
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FDA Panel Unanimously Supports Sofosbuvir for Hepatitis C

Posted by on October 28, 2013

On Friday, the FDA’s Antiviral Drugs Advisory Committee unanimously voted (15-0) to recommended approval of Gilead Sciences Inc’s experimental hepatitis C drug, sofosbuvir (SOF) in combination with ribavirin for the treatment of adults with chronic hepatitis C virus (HCV) genotypes (GT) 2 and 3 infections.
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FDA Panel Recommends Approval of Simeprevir for Hepatitis C

Posted by on October 25, 2013

Yesterday, the US Food and Drug Administration’s (FDA’s) Antiviral Drugs Advisory Committee unanimously recommended simeprevir (Janssen) for the treatment of chronic hepatitis C virus (HCV) genotype 1 (GT1) infection, combined with peginterferon alfa and ribavirin in adults with compensated liver disease (including cirrhosis) who are treatment naïve or who have failed previous interferon therapy with or
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Meeting Materials NOW Available! – Sofosbuvir

Posted by on October 23, 2013

October 25, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Antiviral Drugs Advisory Committee  
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Meeting Materials NOW Available! – Simeprevir

Posted by on October 22, 2013

October 24, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Antiviral Drugs Advisory Committee 
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FDA Supports use of Miltefosine Capsules for Leishmaniasis

Posted by on October 21, 2013

On Friday, a panel of the US Food and Drug Administration (FDA) endorsed miltefosine capsules for the treatment of visceral, cutaneous, and mucosal leishmaniasis.
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AdComm Roll Call Special – Spotlight on: NDAC

Posted by on October 21, 2013

The Nonprescription Drugs Advisory Committee (NDAC) has apowerful voice in guiding FDA policy regarding self-care and is tasked with weighing-in on the safety and effectiveness of over-the-counter (OTC) drugs. The topics of the meetings of NDAC vary, as this committee is responsible for the review of issues affecting currently marketed drugs and also the switch
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FDA Advisory Committee Votes Against Expanded Indication for Vascepa

Posted by on October 17, 2013

The Endocrinologic and Metabolic Drugs Advisory Committee declined to recommend an expanded indication for Amarin Pharmaceutical’s Vascepa (icosapent ethyl). The panel voted 9-2 yesterday against approval of the drug for the proposed new indication that would allow it to be available to a much broader patient population.
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Meeting Announcement – Tasimelteon Capsules

Posted by on October 16, 2013

November 14, 2013 8:00 a.m. to 5:00 p.m.: Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement
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