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.
- Injectafer is indicated:
- for the treatment of iron deficiency anemia (IDA) in adults and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron, and adult patients who have non-dialysis dependent chronic kidney disease
- to improve exercise capacity in people with iron deficiency anemia and New York Heart Association (NYHA) class II/III heart failure.
Development timeline for Injectafer
Date | Article |
---|
Jun 5, 2023 | Approval Injectafer Approved in the U.S. for the Treatment of Iron Deficiency in Adult Patients with Heart Failure |
Dec 16, 2021 | Approval Injectafer (ferric carboxymaltose injection) Receives FDA Approval for the Treatment of Pediatric Patients with Iron Deficiency Anemia |
May 6, 2021 | Approval Injectafer (ferric carboxymaltose injection) Receives FDA Approval for Single Dose Option for the Treatment of Adult Patients with Iron Deficiency Anemia |
Jul 26, 2013 | Approval FDA 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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