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AstraZeneca: FDA To Review NDA For Epanova

18th Sep 2013 07:34

LONDON (Alliance News) - AstraZeneca (AZN.L, AZN) announced the US FDA has accepted for review a New Drug Application, or NDA, for Epanova, an investigational compound for the treatment for patients with severe hypertriglyceridaemia. The NDA was filed by Omthera Pharmaceuticals, now a wholly-owned subsidiary of AstraZeneca, in July, 2013. The PDUFA goal date for the FDA is 5 May 2014.

Omthera holds worldwide rights to Epanova under a license from Chrysalis Pharma AG, a privately held Swiss company that is the owner of the product.

Copyright RTT News/dpa-AFX


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