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Amarin (AMRN) says the FDA has accepted its supplemental new drug application for Vascepa and...

Amarin (AMRN) says the FDA has accepted its supplemental new drug application for Vascepa and set a December 20 target date to complete its regulatory review. The company's seeking approval of the the cholesterol-reducing fish-oil pill as an adjunct to diet for the treatment of high triglycerides with mixed dyslipidemia. Shares +6.2% in pre-market trading.
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Comments (8)
  • OmegaWatcher
    , contributor
    Comments (11) | Send Message
     
    Interesting article on another Prescription Omega-3; Vascazen

     

    http://bit.ly/10b8wbD
    23 Apr 2013, 10:47 AM Reply Like
  • ralphey
    , contributor
    Comments (346) | Send Message
     
    Wow thats an original name - just gotta wonder why if the product is so good they need to copy vascepas name
    23 Apr 2013, 10:56 AM Reply Like
  • OmegaWatcher
    , contributor
    Comments (11) | Send Message
     
    Hi Ralphey -

     

    Vascazen was actually commercialized before Vascepa was on the market. Vascazen is commercialized as a Medical Food to correct an Omega-3 deficiency in Cardiovascular patients, so it deals with a broader patient population than Vascepa or Lovaza.

     

    Just thought the Seeking Alpha readers would be interested in hearing about another prescription only Omega-3 therapy.
    23 Apr 2013, 11:03 AM Reply Like
  • Gary Head
    , contributor
    Comments (226) | Send Message
     
    OmegaWatcher.
    I'm not sure you can Vascazen a " prescription " Omega 3.
    In my experience MD's prescribe FDA approved drugs and /or suggest / recommend dietary supplements regulated as food.

     

    By the way , please post the clinical trial data to show that your product in particular is effective in reducing CV events

     

    Gary
    24 Apr 2013, 11:25 AM Reply Like
  • OmegaWatcher
    , contributor
    Comments (11) | Send Message
     
    Hi Gary -

     

    A Medical Food is a class of products, regulated by the FDA. Vascazen is only available by prescription and is specifically formulated for Cardiovascular patients that are deficient in Omega-3, which is unlike dietary supplements made for the "general population".

     

    The clinical data on Vascazen is being presented at the AHA, ATVB meeting next week.
    24 Apr 2013, 12:47 PM Reply Like
  • oldsalt
    , contributor
    Comments (2) | Send Message
     
    What does the FDA do between now and Dec20Th? I am a small time investor starting from day one .
    23 Apr 2013, 12:03 PM Reply Like
  • mitrado
    , contributor
    Comments (2003) | Send Message
     
    This stock is being severely manipulated. It moves more on some dubious "reporter" articles than on official news from the company itself. The SEC should look into it.
    23 Apr 2013, 12:03 PM Reply Like
  • Michael Bryant
    , contributor
    Comments (5615) | Send Message
     
    Why is it falling?
    23 Apr 2013, 10:18 PM Reply Like
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