Syngene Proposal To Conduct Phase I CT of Ferumoxytol Inj rejected by CDSCO panel
New Delhi: Stating that the proposal submitted by Syngene International could not be considered at present, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected the proposal to conduct the Phase I clinical trial of Ferumoxytol injection.
The drug to be used in the proposed trial is not of Indian origin, as the committee noted in highlighting the cause.
This came after Syngene International presented its proposal for the Phase I clinical trial of Ferumoxytol Injection (30 mg/mL) before the committee.
Ferumoxytol is an intravenous iron replacement product used to treat iron deficiency anaemia (IDA) in patients with chronic kidney disease (CKD) or in patients who are unable to tolerate or have not responded adequately to oral iron supplementation. It works by replenishing iron stores so that the body can make more red blood cells.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.