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Lupin receives US FDA approval for kit used in colonoscopy preparation

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

Topics
US FDA | Lupin

Press Trust of India  |  New Delhi 



Lupin
Lupin.

Pharmaceuticals firm Ltd on Friday said it has launched the generic sodium sulfate, potassium sulfate and magnesium sulfate oral solution, used for cleansing 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, 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.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)


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First Published: Fri, September 09 2022. 12:55 IST

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