Eli Lilly gets CDSCO Panel Nod to Import, Market Antidiabetic Drug Tirzepatide solution for injection Single dose vial
New Delhi: The drug major Eli Lilly has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to import and market the antidiabetic drug Tirzepatide 2.5 mg/0.5 ml, 5mg/0.5ml, 10mg/0.5 ml, 12.5 mg/0.5 ml and 15mg/.5 ml solution for injection (single dose vial).
However, this approval is subject to the condition that the firm should conduct a Phase IV clinical trial and be required to submit the Phase IV clinical trial protocol to CDSCO within 03 months from the date of approval.
This came after the drug maker Eli Lilly presented the proposal for import and marketing permission of Tirzepatide 2.5 mg/0.5 ml, 5mg/0.5ml, 10mg/0.5 ml, 12.5 mg/0.5 ml and 15mg/.5 ml solution for injection (Single dose vial) along with their justification for bioequivalence (BE) and clinical trial (CT) waiver before the committee.
The firm informed that a similar formulation i.e Tirzepatide 2.5 mg/0.5 ml, 5mg/0.5ml, 10mg/0.5 ml, 12.5 mg/0.5 ml, and 15mg/.5 ml injection in the prefilled pen is already approved by the CDSCO for the same indication and now the firm has proposed for formulation in a single-dose vial presentation.
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