Justify dose and rationality: CDSCO Panel Tells Alkem Laboratories on FDC Sacubitril plus Valsartan
New Delhi: In response to the proposal for bioequivalence (BE) study and Phase III clinical trial (CT) waiver for Sacubitril 12mg plus Valsartan 13mg film-coated tablets presented by the drug major Alkem Laboratories, the Subject Expert Committee ( SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm to submit more […]