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