Injectafer 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 History and FDA Approval Process for Injectafer
|Jul 26, 2013|| 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|
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