MSN Laboratories Gets CDSCO Panel Nod To Manufacture, Market Ferumoxytol Injection
New Delhi: Accepting the pharmacokinetics study data and the published literature on global clinical trial data involving 112 Indian patients, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major MSN Laboratories to manufacture and market Ferumoxytol Injection 510 mg of elemental iron/17 mL (30 mg/ml).
However, this approval is subject to the condition that the firm conduct post-marketing surveillance (PMS) of the proposed drug.
This came after MSN Laboratories presented the pharmacokinetic study report of Ferumoxytol injection 510 mg of elemental iron/17 mL (30 mg/ml) along with published literature on global clinical trial data involving Indian patients carried out by the innovator.
Ferumoxytol injection is an iron replacement product that is used to treat iron deficiency anemia (not enough iron in the blood) in patients with chronic kidney disease (CKD) and in patients unable to take oral iron or who had taken oral iron in the past but did not work well.
At the recent SEC meeting for Hematology held on June 18, 2024, the expert panel reviewed the pharmacokinetic study report of Ferumoxytol injection 510 mg of elemental iron/17 mL (30mg/ml) along with published literature on global clinical trial data involving Indian patients carried out by the innovator.
The committee has reviewed the pharmacokinetics study data and found it acceptable.
The firm has also presented the published literature on global clinical trial data involving 112 Indian patients, which the expert panel found acceptable.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market Ferumoxytol injection 510 mg of elemental iron/17 mL (30 mg/mL) with a condition to conduct a PMS study.
Accordingly, the expert panel suggested that the firm submit the PMS study protocol within 3 months from the date of approval to CDSCO.
