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BRIEF-ROCKWELL MEDICAL SAYS FDA REQUESTS EXTRA TIME TO REVIEW CALCITRIOL SUBMISSION
October 25, 2017 / 1:15 PM / in 2 months

BRIEF-ROCKWELL MEDICAL SAYS FDA REQUESTS EXTRA TIME TO REVIEW CALCITRIOL SUBMISSION

Oct 25 (Reuters) - Rockwell Medical Inc:

* ROCKWELL UPDATE ON CALCITRIOL POST-APPROVAL MANUFACTURING SUBMISSION TO FDA

* ROCKWELL MEDICAL INC - ‍FDA HAS REQUESTED EXTRA TIME TO REVIEW ITS POST-APPROVAL DRUG MANUFACTURING SUBMISSION THAT WAS FILED WITH FDA SEPTEMBER 28

* ‍FDA WAS REQUIRED TO PROVIDE ROCKWELL WITH A DETERMINATION ON ITS SEPTEMBER 28(TH) SUBMISSION WITHIN 30 DAYS​

* ROCKWELL MEDICAL INC - ‍ROCKWELL INTENDS TO SELL CALCITRIOL COMMERCIALLY ONCE FDA APPROVES ITS POST-APPROVAL DRUG MANUFACTURING SUBMISSION​

* ‍COMPANY EXPECTS TO HAVE AN ANSWER FROM FDA IN APPROXIMATELY FOUR MONTHS​ Source text for Eikon: Further company coverage:

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