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BRIEF-FDA accepts resubmission of new drug application for rayaldee
2016年4月27日 / 下午4点51分 / 1 年前

BRIEF-FDA accepts resubmission of new drug application for rayaldee

April 27 (Reuters) - Opko Health Inc :

* FDA accepts resubmission of new drug application for rayaldee

* New prescription drug user fee act (PDUFA) date will be Oct. 22, 2016

* Six month review period assigned for resubmitted NDA, and new prescription drug user fee act (PDUFA) date will be Oct. 22, 2016

* FDA in March indicated NDA could not be approved due to deficiencies observed during facility inspection of third party manufacturer Source text for Eikon: Further company coverage:

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