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# After 9 Years, FDA Denies Luitpold INFeD Petition
- URL: https://www.fdaweb.com/after-9-years-fda-denies-luitpold-infed-petition/
- Published: 2016-07-12T12:00:00.000Z
- Updated: 2026-09-14T21:13:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136157

After an unexplained gestation period of nine years, FDA has denied a 7/28/97 Luitpold Pharmaceuticals petition asking the agency to withdraw its approval of the intramuscular route of administration for INFeD, an injectable iron dextran product that at the time of the petition was manufactured by Schein Pharmaceutical. The denial [letter](https://www.regulations.gov/document?D=FDA-1997-P-0353-0010&ref=fdaweb.com) notes that FDA has approved several iron dextran injection products, three of which are relevant to the petition — Imferon, INFeD, and Dexferrum.

The petition was denied, the letter says, because: 

- no conclusions can be drawn from the petition’s calculation of the molecular weights of Imferon and INFeD;
- the petition failed to demonstrate a lack of substantial evidence for the intramuscular indication for Imferon and INFeD;
- the petition failed to demonstrate that intramuscular use of iron dextran is no longer part of current clinical practice; and
- there are no competitive advantages and disadvantages as claimed in the petition.