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FDA seeks more safety data for Injectafer

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Luitpold received a "not approvable" letter from FDA for the iron deficiency anemia drug Injectafer (ferric carboxymaltose), the firm reports March 12. The agency requests additional clinical trials to provide more data about a signal that led the Drug Safety and Risk Management Advisory Committee to vote 12-2 that Injectafer has a mortality disadvantage compared to oral iron (1"The Pink Sheet" Feb. 11, 2008, p. 28). Luitpold is working on new studies to support the application, CEO Mary Jane Helenek says

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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