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Injectafer FDA Approval History

FDA Approved: Yes (First approved July 25, 2013)
Brand name: Injectafer
Generic name: ferric carboxymaltose
Dosage form: Injection
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.

Development Timeline for Injectafer

Jul 26, 2013ApprovalFDA 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 forInjectafer (Ferric Carboxymaltose Injection), a Next GenerationIntravenous Iron Product

Further information

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