CDSCO panel nod to Hetero lab to study Pregabalin, Polmacoxib FDC tablet

Published On 2023-07-26 09:42 GMT   |   Update On 2023-07-26 12:19 GMT
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The drug major Hetero Labs has got approval from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct a bioequivalence (BE) study and Phase III clinical trial of fixed-dose combination (FDC) pregabalin extended released 82.5mg plus polmacoxib 2mg tablet for treating moderate acute, chronic or neuropathic pain.

However, this approval is subject to a condition that the firm should initiate the phase III clinical trial only after submitting the study results of the BE study.

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For more details, check out the link given below:

Hetero Lab Gets CDSCO Panel Nod To Study Pregabalin, Polmacoxib FDC Tablet


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