Justify proposed dose and rationality: CDSCO Panel Tells Lupin on FDC Sacubitril plus Valsartan
New Delhi: In response to the proposal presented by the drug major Lupin for the fixed-dose combination (FDC) cardiovascular drug Sacubitril plus Valsartan, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the more justification on the proposed dose and rationality of the fixed-dose combination (FDC) cardiovascular drug Sacubitril plus Valsartan tablet 25mg.
This came after the drug major Lupin presented its proposal along with justification for bioequivalence (BE) waiver and Phase-III clinical trials (CT) waiver before the committee.
Sacubitril is a prodrug that is activated to sacubitrilat (LBQ657) by de-ethylation via esterases. Sacubitrilat inhibits the enzyme neprilysin, which is responsible for the degradation of atrial and brain natriuretic peptides, two blood pressure–lowering peptides that work mainly by reducing blood volume.
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