Request the Agency to Overturn the Decision to Rescind the Special Protocol Assessment for VASCEPA and to Delay the PDUFA Date for ANCHOR sNDA (sNDA 20257/S-005)

 
Docket ID: FDA-2013-P-1612
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:
CLOSED Petition Denied 4/27/2015
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Overturn the Decision to Rescind the Special Protocol Assessment for VASCEPA and to Delay the PDUFA Date for ANCHOR sNDA (sNDA 20257/S-005)
Keyword(s): PDUFA, Anchor, Vascepa, 2013-10156, 20257/S-005
Legacy ID: 2013-10156
Type: Nonrulemaking
Docket Status: CLOSED
Center: CDER
Docket Item Code: P
 

Primary Documents

View All  (113)
Comment Period Closed
Aug 04, 2014 11:59 PM ET
Other
Posted: 02/04/2014
ID: FDA-2013-P-1612-0069
Comment Period Closed
Aug 04, 2014 11:59 PM ET
Other
Posted: 02/04/2014
ID: FDA-2013-P-1612-0081
Comment Period Closed
Aug 04, 2014 11:59 PM ET
Other
Posted: 02/04/2014
ID: FDA-2013-P-1612-0071
Comment Period Closed
Aug 04, 2014 11:59 PM ET
Other
Posted: 02/04/2014
ID: FDA-2013-P-1612-0079
Comment Period Closed
Aug 04, 2014 11:59 PM ET
Other
Posted: 02/04/2014
ID: FDA-2013-P-1612-0075

Supporting Documents

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Comments Not Accepted
Supporting & Related Material
Posted: 03/27/2015
ID: FDA-2013-P-1612-0231

Comments

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343
Comments Received*
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