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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.
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751