New Delhi: The drug major Dr Reddy's Labs has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the anti-cancer drug Lenalidomide capsules 20mg (additional strength) with Phase-III clinical trial (CT) waiver.
This came after Dr.Reddy’s Labs presented the proposal for manufacturing and marketing permission for Lenalidomide capsules 20mg (additional strength) along with justification for the waiver of Phase-III CT with Bioequivalence study report of Lenalidomide capsules 25mg before the committee.
The firm has informed that the proposed formulation strength 5mg 10 mg, 15mg, and 25 mg of Lenalidomide Capsules 20mg are already approved by CDSCO since 2007 in the country. The proposed strength 20 mg of Lenalidomide capsules are only for dose titration purposes only.
Lenalidomide is a thalidomide derivative used to treat multiple myeloma and anemia in low to intermediate-risk myelodysplastic syndrome. Lenalidomide is an immunomodulatory drug with potent antineoplastic, anti-angiogenic, and anti-inflammatory properties.
Lenalidomide is a drug with multiple mechanisms of action. Lenalidomide exerts immunomodulating effects by altering cytokine production, regulating T-cell co-stimulation, and enhancing NK cell-mediated cytotoxicity.
At the recent SEC meeting for Oncology held on 3rd and 4th April 2024, the expert panel reviewed the proposal presented by the drug major Dr Reddy's Labs to manufacture and market Lenalidomide capsules 20mg (additional strength) along with justification for the waiver of Phase-III CT with Bioequivalence study report of Lenalidomide capsules 25mg before the committee.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market Lenalidomide capsules 20mg (additional strength) with a Phase-III clinical trial waiver.
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