Biopharmaceutical company Rockwell Medical Inc (NASDAQ:RMTI) reported on Monday the receipt of US FDA approval for the manufacture of its Abbreviated New Drug Application for Calcitriol through its contract manufacturing organisation (CMO).
The company added Calcitriol is its US FDA approved active vitamin D injection for the management of hypocalcemia in patients undergoing chronic hemodialysis.
Earlier this month, the company received US FDA approval of its Prior Approval Supplement for Calcitriol in order to market and commercialise in the US.
Following the manufacturing update for CMO's approval, the US FDA had provided a target date for a response no later than 19 August 2018. The company will provide additional information regarding its plans for commercial production and sales of Calcitriol in the US as it moves forward.
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