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Rockwell receives FDA approval to begin manufacturing Calcitriol
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Rockwell Medical Inc. reported that it has received FDA approval to begin manufacturing Calcitriol, the company’s active vitamin D injection for the management of hypocalcemia in patients undergoing chronic hemodialysis.
In a press release, Rockwell said FDA action on its prior approval supplement “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 (CMO). Rockwell submitted a manufacturing update to the FDA to approve the CMO. Rockwell said it does not expect Calcitriol sales to have a material impact on its total revenue for 2018.
Rockwell is still recovering from its split with former board chair and company CEO Robert Chioini and other top executives after forcing them to step down in late May. On July 2, the company filed a lawsuit in the United States District Court for the Eastern District of Michigan against Chioini, along with former chief financial officer (CFO) Thomas Klema, board member Ron Boyd and former board member Patrick Bagley, the company said in another press release.
According to Rockwell, the lawsuit alleges that Chioini, Klema, Boyd and Bagley have mismanaged the company, promoting self-enrichment and poor corporate governance at the expense of Rockwell Medical's shareholders, employees and patients in need of the company’s drug Triferic, which is indicated for iron replacement and maintenance of hemoglobin in patients on hemodialysis.
“Their recent continued attempts to paralyze the board’s and the company’s ability to operate follows a long-line of wrongful acts that are outlined in the lawsuit,” according to the release. The lawsuit also outlines the timing and rationale for the board’s decision to terminate Chioini and Klema, the company said.
Ben Wolin, chairman of Rockwell’s board, said in the release, “Importantly, the five independent directors of the board are continuing to make progress on the significant efforts underway to put the company on stable footing, including identifying and hiring a new CEO and CFO, engaging a new audit firm and implementing our new Triferic commercialization strategy.”
References:
ir.rockwellmed.com/news-releases/news-release-details/rockwell-medical-provides-investor-update