Glenmark Pharma receives approval from the US health regulator for a generic drug

Glenmark Pharmaceuticals on Wednesday said it has received approval from the US health regulator to market Sodium Phenylbutyrate tablets, used in treating urea cycle disorders, in America.

The company has received final approval from the US Food and Drug Administration (USFDA) for the product which is a generic version of Horizon Therapeutics' Buphenyl, the Mumbai-based drug maker said in a statement. According to IQVIA sales data for 12-month period ended September 2022, Buphenyl had annual sales of around USD 8.7 million. Glenmark's current portfolio consists of 177 products authorized for distribution in the US marketplace and 46 abbreviated new drug applications (ANDAs) pending approval with the USFDA.