New Delhi: Zuventus Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Ferrous Ascorbate suspension 30 mg/5 ml indicated for the treatment of iron deficiency anaemia with bioequivalence (BE) and clinical trial (CT) waiver.
This came after Zuventus Healthcare presented safety and efficacy data in children for ferrous ascorbate suspension 30 mg/5 ml indicated for the treatment of iron deficiency anaemia along with the request for waiver of clinical trial study and bioequivalence (BE) study before the committee.
The Committee noted that various fixed-dose combinations (FDC) suspension formulations of ferrous ascorbate have already been approved by CDSCO and are available on the market.
Ferrous ascorbate is a medication used to treat iron deficiency anemia. Iron is necessary for the production of hemoglobin. Iron-deficiency can lead to decreased production of hemoglobin and a microcytic, hypochromic anemia.
At the recent SEC meeting for hematology held on 10th September 2024, the expert panel reviewed the safety and efficacy data in children for ferrous ascorbate suspension 30mg/5ml indicated for the treatment of iron deficiency anaemia along with the request for waiver of clinical trial study and BE study before the committee.
After detailed deliberation, the Committee recommended the grant of permission to manufacture and market Ferrous Ascorbate suspension 30 mg/5 ml with BE and CT waiver based on the data presented by the firm, subject to submission of chemistry, manufacturing, and controls data (CMC) data.
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