May 8, 2018 / 12:45 PM / in 15 days

BRIEF-Rockwell Medical Update On Calcitriol New Manufacturing Submission To FDA

May 8 (Reuters) - Rockwell Medical Inc:

* ROCKWELL MEDICAL UPDATE ON CALCITRIOL NEW MANUFACTURING SUBMISSION TO FDA

* ROCKWELL MEDICAL INC - FOR CALCITRIOL VITAMIN D INJECTION, FDA HAS PROVIDED TARGET DATE FOR A RESPONSE TO SUBMISSION OF NO LATER THAN AUG 19, 2018

* ROCKWELL MEDICAL - AWARE THAT FDA IS CONDUCTING PRE-APPROVAL INSPECTION OF CONTRACT MANUFACTURING ORGANIZATION’S (CMO’S) LAB PARTNER ON JUNE 25, 2018

* ROCKWELL MEDICAL INC - STABILITY DATA THAT WAS PROVIDED IN CALCITRIOL SUBMISSION REMAINS WITHIN SPECIFICATION

* ROCKWELL MEDICAL INC - FDA HAS CONFIRMED CALCITRIOL VITAMIN D INJECTION IS UNDER EXPEDITED REVIEW

* ROCKWELL MEDICAL INC - NOW AWAITING FDA APPROVAL OF A NEW CONTRACT MANUFACTURER IN ORDER TO COMMERCIALIZE CALCITRIOL Source text for Eikon: Further company coverage:

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