CDSCO Panel grants Intas Package Insert update for Pegfilgrastim solution for injection 6mg/0.6mL vial and PFS
New Delhi: The Subject Expert Committee (SEC) functional under the Center Drug Standard Control Organisation (CDSCO) has approved drug major Intas Pharmaceutical to update the package insert of the 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.
This came after the drug major Intas Pharmaceutical presented the proposal for approval of revision in the package insert for the product Pegfilrastim (pegylated recombinant human granulocyte colony-stimulating factor) solution for injection 6mg/0.6mL single-use vial and pre-filled syringe (PFS) and 6mg/1.0mL single use PFS in line with innovator product.
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.
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