MSN Laboratories Gets CDSCO Panel nod to Manufacture, Market Tolvaptan Tablets 7.5 mg
New Delhi: Considering the published data on efficacy studies of Tolvaptan Tablets 7.5 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to MSN Laboratories to manufacture and market Tolvaptan Tablets 7.5 mg.
However, this approval is subject to the condition that the firm should conduct the Phase IV clinical trial for efficacy.
This came after MSN Laboratories presented the literature on additional efficacy data on Tolvaptan tablets 7.5 mg, approved by the European Medicines Agency (EMA).
Tolvaptan is used to treat hyponatremia (low sodium in the blood) in patients with heart failure or syndrome of inappropriate antidiuretic hormone (SIADH). Tolvaptan is also used to slow kidney function decline in adults who are at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
Tolvaptan is a selective vasopressin V2-receptor antagonist to slow kidney function decline in patients at risk for rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). It is also used to treat hypervolemic and euvolemic hyponatremia.
Tolvaptan is a selective and competitive arginine vasopressin receptor 2 antagonist. Vasopressin acts on the V2 receptors found in the walls of the vasculature and luminal membranes of renal collecting ducts. By blocking V2 receptors in the renal collecting ducts, aquaporins do not insert themselves into the walls, thus preventing water absorption. This action ultimately results in an increase in urine volume, decrease urine osmolality, and increase electrolyte-free water clearance to reduce intravascular volume and an increase in serum sodium levels. Tolvaptan is especially useful for heart failure patients as they have higher serum levels of vasopressin.
At the recent SEC meeting for renal held on 12th November 2024, the expert panel reviewed the literature on additional efficacy data on Tolvaptan tablets presented by MSN Laboratories.
After detailed deliberation, the committee recommended the grant of permission for manufacturing and marketing of Tolvaptan tablets 7.5 mg considering the published data on efficacy studies submitted by the firm, subject to the condition that the firm shall conduct the Phase IV clinical trial for efficacy.
Accordingly, the expert panel suggested that the firm should submit a Phase IV clinical trial (CT) protocol within 3 months from the date of approval to CDSCO for further review by the committee.
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