FDA approves efficacy supplement for Pharmacosmos's Monoferric

The U.S. Food and Drug Administration approved a supplemental application for Monoferric, an intravenous iron product sponsored by Pharmacosmos, with a submission status date of October 23, 2026. The filing was submission number 6, classified as an efficacy supplement, under application number NDA208171, and was marked as approved with standard review priority.¹

Monoferric contains the active ingredient ferric derisomaltose and is formulated as an intravenous solution. The FDA record lists three product strengths: 1GM/10ML, 100MG/ML, and 500MG/5ML, all delivering a concentration of 100MG/ML.¹

The record identifies Pharmacosmos as the sponsor of the application. The FDA's public drug approval database does not provide further detail in this entry on the specific clinical data or labeling changes tied to this particular efficacy supplement. Readers seeking the underlying clinical rationale or label changes associated with submission 6 would need to consult the FDA's approval letter or updated prescribing information, which are not included in this record.