Submit justification: CDSCO panel tells Hetero for FDC Lacosamide, Brivaracetam

In line with the drug maker Hetero Pharma's proposal for the fixed-dose combination Lacosamide plus Brivaracetam, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the justification in respect to the combination drug to the CDSCO for further review by the committee.

This came after the drug maker Hetero Pharma presented its proposal along with bioequivalence (BE) and Phase III clinical trial protocol before the committee.

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Submit Justification: CDSCO Panel Tells Hetero For FDC Lacosamide, Brivaracetam