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Edho approve ayyindi AntA koneyocha AMRN....

 

 

Amarin confirms that a federal district judge has granted its motion for summary judgment in the company's lawsuit against the US FDA (AMRN) : Co believes based on the court's ruling that Vascepa is entitled to five-year marketing exclusivity starting from FDA's approval of Vascepa in July 2012, thus extending NCE exclusivity through July 25, 2017. 

  • The ruling also confirms that acceptance by FDA of abbreviated new drug applications for generic versions of Vascepa is not permitted until July 2016. 
  • The related statutory 30-month stay triggered by patent litigation following generic application resubmissions in July 2016 would then expire in January 2020
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Amarin confirms that a federal district judge has granted its motion for summary judgment in the company's lawsuit against the US FDA (AMRN) : Co believes based on the court's ruling that Vascepa is entitled to five-year marketing exclusivity starting from FDA's approval of Vascepa in July 2012, thus extending NCE exclusivity through July 25, 2017. 

  • The ruling also confirms that acceptance by FDA of abbreviated new drug applications for generic versions of Vascepa is not permitted until July 2016. 
  • The related statutory 30-month stay triggered by patent litigation following generic application resubmissions in July 2016 would then expire in January 2020

 

denni approve avvadam antara...brahmilaughing.gif

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denni approve avvadam antara...brahmilaughing.gif

 

paina Approval vachindhani.. anukunnaru..  andhuke post chesaa... Tempry Raise ee adhi ani cheppataniki

 

 aa mathramm theleitledhaa  meku   :o

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paina Approval vachindhani.. anukunnaru..  andhuke post chesaa... Tempry Raise ee adhi ani cheppataniki

 

 aa mathramm theleitledhaa  meku   :o

teleedu...meeru septhiri kada...iffude telsindi..brahmilaughing.gif

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