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