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However, these results were not statistically significant

Sections 502 and 510 of the FDCA deem a drug misbranded if it is marketed for off-label uses, and Section 331 of the FDCA prohibits the marketing and promotion of a Class III device for an unapproved use

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A prospective, placebo-controlled, randomized study (NCT00940602) found that DFX significantly reduced the combined risk of hospitalization for worsening heart function or congestive heart failure in MDS patients, but had no significant effect on left ventricular ejection fraction or pulmonary artery pressure