Justify dose and rationality: CDSCO Panel Tells Alkem Laboratories on FDC Sacubitril plus Valsartan
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2023-12-24 12:00 GMT | Update On 2024-03-22 17:23 GMT

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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 justification on the proposed dose and rationality of the fixed-dose combination of Sacubitril plus valsartan.
This came after Alkem Laboratories presented their proposal along with justification for the BE waiver and Phase III CT waiver before the committee.
Sacubitril is a neprilysin inhibitor used in combination with valsartan as an adjunct to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
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