Emcure gets CDSCO Panel Nod To Manufacture, Market ferric Carboxymaltose injection 50mg/ml
New Delhi: Emcure Pharmaceuticals has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Ferric carboxymaltose injection 50 mg/ml indicated for the treatment of iron deficiency in children and adolescents aged >1 year when oral iron preparations are ineffective or cannot be used.
However, the nod is subject to the condition that the firm should conduct a Phase IV clinical trial in 300 pediatric children and adolescents aged > 1 year age.
This came after Emcure Pharmaceuticals presented the proposal for the manufacture and marketing of Ferric carboxymaltose injection 50 mg/ml indicated for the treatment of iron deficiency in children and adolescents aged >1 year when oral iron preparations are ineffective or cannot be used (Additional Indication) along with justification/rationale for a clinical trial waiver before the committee.
Ferric carboxymaltose injection is used to treat iron-deficiency anemia (a lower than normal number of red blood cells due to too little iron) in adults and children 1 year of age and older who cannot tolerate or who could not successfully be treated with iron supplements taken by mouth.
Intravenous administration of ferric carboxymaltose results in transient elevations in serum iron, serum ferritin, and transferrin saturation, and, ultimately, in the correction of haemoglobin levels and replenishment of depleted iron stores.
At the recent SEC meeting for the oncology and hematology held on 12th September 2023, the expert panel reviewed the proposal presented by Emcure Pharmaceuticals for the manufacture and marketing of Ferric carboxymaltose injection 50 mg/ml indicated for the treatment of iron deficiency in children and adolescents aged >1 year when oral iron preparations are ineffective or cannot be used.
The firm has informed that Ferric carboxymaltose injection of 50 mg/ml has already been approved by the United States Food and Drug Administration (USFDA) in 2022 and by the European Medicines Evaluation Agency (EMEA) in 2023 for the treatment of pediatric patients with iron deficiency anemia.
After detailed deliberation, the committee recommended the grant of permission to manufacture and marketing of Ferric carboxymaltose injection 50 mg/ml for a proposed additional indication with a clinical trial waiver subject to the condition that the firm should conduct an Phase IV clinical trial in 300 pediatrics children and adolescents aged > 1 year age.
Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 03 months from the date of approval for further review by the committee.
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