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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-02-05T18:00:57+05:30 | Updated On 22 March 2024 9:47 PM IST

Intas Gets CDSCO Panel Nod to Study R-hFSH

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.

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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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751