Laurus Lab Gets CDSCO Panel Nod To Manufacture and Market Sodium Phenylbutyrate Powder
New Delhi: Noting that urea cycle disorder is a very rare disease and there are unmet medical needs in the country, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to Laurus Lab to manufacture and market Sodium Phenylbutyrate powder.
However, this approval is subject to the condition that the firm should conduct a Phase IV clinical trial for which Phase IV clinical trial protocol is to be submitted to CDSCO within 3 months.
Sodium phenylbutyrate is used together with a proper diet to help treat urea cycle disorders, including carbamyl phosphate synthetase deficiency (CPS), ornithine transcarbamylase deficiency (OTC), or argininosuccinate synthetase (AS).
Sodium phenylbutyrate metabolites allow the kidneys to excrete excess nitrogen in place of urea and coupled with dialysis, amino acid supplements, and a protein-restricted diet, children born with urea cycle disorders can usually survive beyond 12 months. Patients may need treatment for all their life.
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