Glenmark gets USFDA nod to market generic medication

Glenmark Pharmaceuticals on Monday said it has received approval from the US health regulator to market a generic product used to treat schizophrenia and in some cases to control severe nausea.

The company has received nod from the US Food & Drug Administration (USFDA) for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the Mumbai-based drug maker said in a statement.

The company's product is the generic version of GlaxoSmithKline's Compazine tablets, it added.

According to IQVIA sales data for the 12-month period ending January 2023, the Compazine tablets 5 mg and 10 mg achieved annual sales of around USD 26.9 million.

Glenmark said its current portfolio consists of 182 products authorised for distribution in the US marketplace and 46 ANDAs (Abbreviated New Drug Applications) pending approval with the USFDA.

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