Lupin receives US FDA approval for generic Suprep bowel prep kit

The company has also received US drug regulator's nod for generic Percocet tablet, a pain killer

Lupin receives US FDA for electrolyte replenisher

premium

BS B2B Bureau Mumbai

Last Updated : Feb 28 2017 | 1:35 PM IST

Lupin Ltd has received final approval for its sodium sulfate, potassium sulfate, and magnesium sulfate oral solution, 17.5 g/3.13 g/1.6 g per 6 ounces, from the US Food and Drug Administration (FDA) to market a generic version of Braintree Laboratories’ Suprep bowel prep kit.

According to Lupin, it is eligible for 180 days of generic drug exclusivity for the approved product, which indicated for cleansing of the colon in preparation for colonoscopy in adults. As per IMS (MAT December 2016), Suprep bowel prep kit had US sales of $ 207.2 million.

Meanwhile, Lupin Limited has also received final approval for its oxycodone & acetaminophen tablet (2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg) from the US drug regulator. The approved product is a generic version of Vintage Pharmaceuticals’ Percocet tablet, which is indicated for relief of moderate to moderately severe pain. According to IMS Health, Percocet tablet recorded annual US sales of $ 838.7 million in 2016.