Glenmark Pharma gets USFDA nod for generic version of Buphenyl tablets
BUPHENYL is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).;
Mumbai: Glenmark Pharmaceuticals Limited has announced that the company has received final approval from the United States Food & Drug Administration (U.S. FDA) for Sodium Phenylbutyrate Tablets USP, 500 mg.
The product is a generic version of Buphenyl Tablets, 500 mg, of Horizon Therapeutics, LLC. Glenmark's Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.
BUPHENYL is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with the late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy.
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