FDA supports new treatment for Amarin's Vascepa capsule
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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, Amarin(http://announced that the U.SFDA(http://endocrine metabolismdrug(http://Advisory(http://Committee (EMDAC) supports the company's development of Vascepa capsules as a new treatment to reduce the risk of adverse cardiovascular eventsThe FDA is expected to respond to the drug's supplementary
(http://application (sNDA) on December 28 this yearAbout Vascepa (AMR101)Vascepa (AMR101) is made up of a high-purity icosapent ethyl derived from the natural fish oil ingredient omega-3 fatty acids, which are produced using an FDA-regulated manufacturing process to remove impurities and retain active ingredients Vascepa is a prescription drug that the FDA identifies as a new chemical entity, not a dietary supplement like regular fish oil Vascepa's unique clinical characteristics have resulted in a number of patented (http:// , including the ability to reduce triglyceride levels in patients without raising LDL-C levels Previously, it had been approved by the FDA to reduce triglyceride levels in patients with severe high triglycerides Vascepa's sNDA is based on the results of a Phase 3 clinical study called REDUCE-IT results from the (http:// showed that Vascepa reduced the overall risk of adverse cardiovascular events by 30 percent compared to the placebo group In addition, Vascepa reduced the risk of the first major adverse cardiovascular events by 25%
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