CDSCO Panel grants Intas Pharma's proposal for additional pack of Romiplostim Injection 125 mcg/vial

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-01-16T17:30:22+05:30 | Updated On 22 March 2024 10:18 PM IST

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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Intas Pharmaceutical's proposal for an additional pack of Romiplostim Injection (r-DNA Origin) 125 mcg/vial.

This came after Intas Pharmaceuticals presented the proposal for an additional pack of Romiplostim Injection (rDNA Origin) 125 mcg/vial to already approved Romiplostim Powder and Solvent for Solution for Injection 250 mcg and 500 mcg (in Vial) packs.

Romiplostim is a thrombopoietin receptor agonist that activates intracellular transcriptional pathways via c-Mpl to increase the production of platelets. It also works similarly to thrombopoietin (TPO), an endogenous glycoprotein hormone that regulates the production of platelets in the bone marrow.

Romiplostim injection is used to increase the number of platelets (cells that help the blood to clot) to decrease the risk of bleeding in adults who have immune thrombocytopenia (ITP; idiopathic thrombocytopenic purpura; an ongoing condition that may cause easy bruising or bleeding due to an abnormally low number of platelets in the blood).

At the recent SEC meeting for Oncology and Hematology held on 7th & 8th December 2023, the expert panel reviewed the proposal presented by the drug major Intas Pharmaceutical for an additional pack of Romiplostim Injection (rDNA Origin) 125 mcg/vial to already approved Romiplostim Powder and Solvent for Solution for Injection 250 mcg and 500 mcg (in Vial) packs.

After detailed deliberation, the committee recommended the approval of the additional pack of Romiplostim Injection (rDNA Origin) 125 mcg/vial to the firm.

Also Read: AstraZeneca Gets CDSCO Panel Nod for Enhertu 100mg for additional indication of breast cancer

intas pharmacdscoromiplostimIntas Pharmaceutical

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