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Ferumoxytol May Get FDA Decision by Year's End
The FDA has designated AMAG Pharmaceuticals’ resubmission for its iron-deficiency anemia treatment ferumoxytol as a complete Class 1 response and plans to make a marketing approval decision by Dec. 30. The company submitted its NDA in December 2007 and received the agency’s complete response letter requesting additional information in October. Ferumoxytol has the potential to replace IV iron infusion treatments, AMAG spokeswoman Kristen Galfetti said.
Washington Drug Letter |
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