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Press Release

May 11, 2021
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FDA approves single-dose Injectafer treatment for patients with iron deficiency anemia

Source:

Press Release

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Daiichi Sankyo Inc. and American Regent Inc. announced FDA approval of Injectafer, a ferric carboxymaltose injection, for the treatment of adult patients with iron deficiency anemia, according to a press release.

Injectafer treats patients with anemia who have an intolerant or insufficient response to oral iron or who have non-dialysis dependent chronic kidney disease. The FDA approved a single 1,000 mg dose option. A two-dose, once weekly, 750 mg treatment was approved in 2013.

“We are pleased to build on the proven, mainstay Injectafer 1,500 mg two-dose course of treatment with the approval of this new 1,000 mg single-dose option,” Linda Mundy, chief medical officer at American Regent, said in the release. “More than 1.7 million patients have been treated with Injectafer in the U.S. and health care providers now have an additional dosing option for adult patients with iron deficiency anemia.”

The FDA approved the 1,000 mg treatment for patients who weigh 110 pounds or more. Daiichi Sankyo expects the single-dose injection to become available in the coming weeks, according to the release.