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BRIEF-Adamis receives response letter from FDA for its epinephrine syringe
2016年6月6日 / 上午10点57分 / 1 年前

BRIEF-Adamis receives response letter from FDA for its epinephrine syringe

June 6 (Reuters) - Adamis Pharmaceuticals :

* FDA indicated that in order to support approval of product, company must expand its human factors study

* Believes that it can finalize study protocols with FDA and complete additional testing within a “relatively short period of time”

* Believes that it can submit data back to FDA sometime in second half of 2016

* Receives complete response letter from FDA for its epinephrine pre-filled syringe NDA Source text for Eikon: Further company coverage: (Bengaluru Newsroom: +1-646-223-8780)

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