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

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