Injectafer Approval History

  • FDA approved: Yes (First approved July 25th, 2013)
  • Brand name: Injectafer
  • Generic name: ferric carboxymaltose
  • Company: Luitpold Pharmaceuticals, Inc.
  • Treatment for: Iron Deficiency Anemia

Injectafer (ferric carboxymaltose) is an iron replacement product indicated for the treatment of iron deficiency anemia.

FDA Approval History for Injectafer

DateArticle
Jul 26, 2013Approval FDA Approves Injectafer for Iron Deficiency Anemia
Jul 26, 2012Luitpold Pharmaceuticals, Inc. Receives Complete Response Letter for Injectafer from the U.S. Food and Drug Administration
Oct 13, 2011Luitpold Pharmaceuticals, Inc. Submits Injectafer NDA to the U.S. Food and Drug Administration
Mar 12, 2008Luitpold Pharmaceutical’s Injectafer (ferric carboxymaltose injection) Receives Non-Approvable Letter From FDA
Feb  4, 2008Luitpold Pharmaceuticals, Inc., Comment on FDA Advisory Committee Meeting to Evaluate Injectafer (Ferric Carboxymaltose Injection)
May 14, 2007Luitpold Pharmaceuticals, Inc., Announces NDA Submission for Injectafer (Ferric Carboxymaltose Injection), a Next Generation Intravenous Iron Product

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