Dr. Reddy’s Lab gets subject expert committee (SEC- Oncology & Haematology) recommendation for Lenalidomide Capsule. The 148th meeting was held on 11.05.2023 at CDSCO (HQ) New Delhi.
Dr. Reddy’s Lab presented the proposal for manufacturing and marketing permission of Lenalidomide Capsule 25mg (using Lenalidomide povidone premix) along with the results of the BE study before the committee.
After detailed deliberation, the committee recommended grant of permission for manufacturing and marketing of Lenalidomide capsule 25mg (using Lenalidomide povidone premix).
The proposed indication is for the treatment of patients with transfusion dependent anaemia due to low or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in combination with Dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy.
