Zydus Lifesciences gets CDSCO panel nod to conduct bioequivalence study of Eltrombopag for oral suspension
New Delhi: Zydus Lifesciences has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioequivalence study of Eltrombopag for oral suspension 12.5 mg and 25 mg.
This came after Zydus Lifesciences presented the proposal for a grant of permission to manufacture and market Eltrombopag for Oral Suspension 12.5mg and 25mg along with a bioequivalence study protocol and justification for a waiver of the Phase-III clinical trial before the committee.
The committee noted that Eltrombopag for Oral Suspension 12.5mg and 25mg is already approved in the US, UK, and Europe and also that the tablet dosage form is already approved in India. Eltrombopag for oral suspension, 12.5 mg and 25 mg, will be helpful in the dose titration.
Eltrombopag is an oral medication used to treat low platelet counts in adults and children with chronic immune thrombocytopenia (ITP). ITP is a blood disorder that can cause unusual bleeding or bruising. Eltrombopag works by binding to the thrombopoietin receptor, which signals the bone marrow to produce more platelets, increasing the number of cells that help blood clot.
Eltrombopag is used to treat thrombocytopenia (low platelets in the blood) in patients with a blood disorder called chronic immune thrombocytopenia (ITP). This medicine is used after a splenectomy (surgery to remove the spleen) and other medicines (e.g., steroids or immunoglobulin) have not worked well enough.
At the recent SEC meeting held on 6th March 2025, the expert panel reviewed the proposal for the grant of permission to manufacture and market Eltrombopag for Oral Suspension 12.5mg and 25mg along with the bioequivalence study protocol and justification for the waiver of the Phase-III clinical trial.
After detailed deliberation, the committee recommended granting permission to conduct a bioequivalence study as per the protocol presented by the firm.
In accordance with the above, the expert panel suggested that the firm should submit a BE report to CDSCO for further necessary action.
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