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Injectafer is contraindicated in patients with hypersensitivity to Injectafer or any of its inactive components.
Biopharmaceutical company AMAG Pharmaceuticals (NasdaqGS:AMAG) reported on Wednesday the admission of the first patient under its head-to-head, Phase 3 clinical trial to evaluate the safety of Feraheme (ferumoxytol) compared to Injectafer (ferric carboxymaltose injection) in adults with iron deficiency anemia (IDA).
The Food and Drug Administration has issued a "not approvable" letter to Luitpold Pharmaceuticals for its ferric carboxymaltose injection (Injectafer), leaving the company to conduct additional clinical trials for the drug as first-line treatment of iron deficiency anemia in women with postpartum and heavy uterine bleeding.
But Daiichi Sankyo Co., Japan's third-largest drugmaker, failed to win approval for the anemia treatment Injectafer and must perform more tests to address concerns that the medicine may increase the risk of death.
-- Concerns about off-label use and a mortality safety signal associated with treatment in clinical trials swayed a federal advisory panel against supporting the approval of ferric carboxymaltose injection (Injectafer), a new intravenous iron product, as a first-line treatment for iron deficiency anemia in postpartum women and in women with heavy uterine bleeding.
-- A federal advisory panel voted against supporting the approval of ferric carboxymaltose injection (Injectafer), a new intravenous iron product, as a first-line treatment for iron deficiency anemia in postpartum women and in women with heavy uterine bleeding.
We believe that this broad approval, together with the recent clinical trial data on Feraccru that showed it to be non-inferior in treatment effect to Ferinject/ Injectafer, the leading IV iron therapy, can lead to a change in the current paradigm for the treatment iron deficiency anaemia.'
An alternative regimen is to administer 750 mg of ferrous carboxymaltose (Injectafer, Luitpold Pharmaceuticals) over 15 minutes, which is an FDA-approved regimen.
New revenue contributors include Pralia, an osteoporosis treatment, which is also being investigated in Phase III studies in breast cancer and rheumatoid arthritis, and subsidiary Luitpold Pharmaceuticals gained FDA approval for Injectafer to treat iron deficiency anemia, a condition that afflicts 7.5 million people in the U.S.
13 October 2011 - Japanese Daiichi Sankyo Company Limited (TYO:4568) said today its Luitpold Pharmaceuticals Inc subsidiary had filed a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Injectafer (ferric carboxymaltose injection) for the treatment of iron deficiency anemia.
Several panelists said they thought that Injectafer was a more practical alternative to the other intravenous iron products currently available, and that more data were available for Injectafer.