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