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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: Daiichi Sankyo Inc.
Treatment for: Iron Deficiency Anemia

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

Development timeline for Injectafer

DateArticle
Jun  5, 2023Approval Injectafer Approved in the U.S. for the Treatment of Iron Deficiency in Adult Patients with Heart Failure
Dec 16, 2021Approval Injectafer (ferric carboxymaltose injection) Receives FDA Approval for the Treatment of Pediatric Patients with Iron Deficiency Anemia
May  6, 2021Approval Injectafer (ferric carboxymaltose injection) Receives FDA Approval for Single Dose Option for the Treatment of Adult Patients with Iron Deficiency Anemia
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 forInjectafer (Ferric Carboxymaltose Injection), a Next GenerationIntravenous Iron Product

See also

Injectafer (ferric carboxymaltose) Consumer information

Further information

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