Ferric derisomaltose

FDA Drug Profile — Monoferric

Drug Details

Generic Name
Ferric derisomaltose
Brand Names
Monoferric
Application Number
NDA208171
Sponsor
Pharmacosmos Therapeutics Inc.
NDC Codes
3
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
FERRIC DERISOMALTOSE

Indications and Usage

1 INDICATIONS AND USAGE Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron who have non-hemodialysis dependent chronic kidney disease (NDD-CKD) MONOFERRIC is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron. ( 1 ) who have non-hemodialysis dependent chronic kidney disease. ( 1 )