Lupin receives US FDA approval for generic Suprep Bowel Prep Kit

New Delhi: Pharmaceuticals firm Lupin Ltd on Friday said it has launched the generic sodium sulfate, potassium sulfate and magnesium sulfate oral solution, used for cleansing the colon as a preparation for colonoscopy, in the US market following approval from the country's health regulator. The approval by the US Food and Drug Administration (USFDA) is for sodium sulfate, potassium sulfate and magnesium sulfate oral solution of strength 17.5 g/3.13 g/1.6 g per 6 ounces, Lupin Ltd said in a regulatory filing.

The approved oral solution is a generic equivalent of Suprep Bowel Prep Kit Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces, of Braintree Laboratories Inc, it added.

The solution had an estimated annual sales of USD 202 million in the US, the company said citing IQVIA MAT July 2022 data.