CDSCO Panel grants Intas Package Insert update for Pegfilgrastim solution for injection 6mg/0.6mL vial and PFS

Pegfilgrastim is a recombinant human granulocyte colony-stimulating factor used to stimulate the production of neutrophils and prevent febrile neutropenia or infections after myelosuppressive chemotherapy.

Pegfilgrastim injection is used to treat neutropenia (low white blood cells) that are caused by cancer medicines. It is a synthetic (man-made) form of a substance that is naturally produced in your body called a colony-stimulating factor. Pegfilgrastim helps the bone marrow to make new white blood cells.

Pegfilgrastim increases the proliferation and differentiation of neutrophils from committed progenitor cells, induces maturation, and enhances the survival and function of mature neutrophils, resulting in dose-dependent increases in neutrophils.

At the recent SEC meeting for hematology held on the 17th of January 2024, the expert panel reviewed the proposal for the approval of revision in the package insert for the product Pegfilgrastim (pegylated recombinant human granulocyte colony-stimulating factor) solution for injection 6mg/0.6mL single-use vial and PFS and 6mg/1.0mL single use PFS in line with innovator product presented by the drug major Intas Pharmaceutical.

After detailed deliberation, the committee recommended approval of the updated package insert version 02 dated January 2023 for the product Pegfilgrastim (pegylated recombinant human granulocyte colony-stimulating factor) solution for injection 6mg/0.6mL single-use vial and PFS and 6mg/1.0mL single use PFS.

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