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Lupin gets USFDA nod to market pain relief, colonoscopy drugs

Tuesday, Feb 28, 2017,12:51 IST By anju A A A

New Delhi | Pharma major Lupin Ltd has received final approval from the USFDA to market a pain relief drug and an oral solution used in colonoscopy.

In a BSE filing, Lupin said it has “received final approval for its Oxycodone and Acetaminophen Tablets USP, 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg from the United States Food and Drug Administration (FDA) to market a generic version of Vintage Pharmaceuticals LLC’s Percocet tablets”.

The approved product is indicated for relief of moderate to moderately severe pain. Percocet tablets had US sales of USD 838.7 million.

In a separate filing, Lupins said it also “received final approval for its sodium sulfate, potassium sulfate, magnesium sulfate oral solution, 17.5 g/3.13 g/1.6 g per ounces from the United States Food and Drug Administration (FDA) to market a generic version of Braintree Laboratories’ Suprep Bowel Prep Kit”.

The approved product is indicated for cleansing of the colon in preparation of colonoscopy in adults. Suprep Bowel Prep Kit had US sales of USD 207.2 million.

Lupin said it will commence promoting both the products shortly.

Shares of Lupin were trading 0.49 per cent higher at Rs 1,471 on the BSE.