On July 11, 2018, Rockwell Medical received FDA approval of its Prior Approval Supplement for manufacturing Calcitriol. This approval was necessary in order to market and commercialize Calcitriol in the United States. Calcitriol is FDA approved under an Abbreviated New Drug Application and is manufactured through a contract manufacturing organization. As previously announced, the Company submitted a manufacturing update to the FDA to approve the CMO and the FDA had provided a target date for a response to Rockwell Medical's submission no later than August 19, 2018.
Rockwell will provide additional information regarding its plans for commercial production and sales of Calcitriol in the United States as it moves forward.