Strides Arcolab gets USFDA nod for bowel-cleansing medicine

NEW DELHI: Drug maker Strides Arcolab today announced receipt of approval from US health regulator for selling medicine used for cleansing the bowel prior to colonoscopy.

The company has received nod from the US Food and Drug Administration for oral solution of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium, Strides Arcolab said in a filing to the BSE.

The approval of the oral solution is for strength of 420 grams of Glycol 3350, 11.2 grams of sodium chloride, 5.72 grams of sodium bicarbonate and 1.48 grams of potassium per 4 litres.

The product will be manufactured at the company's oral dosage facility in Bengaluru and marketed by Strides in the US, it added.

The oral solution is used for bowel cleansing prior to colonoscopy. Polyethylene glycol 3350 is an osmotic laxative and along with electrolytes, it is used in preparation of colonoscopy in adults and paediatric patients of six years and above.

Citing IMS data, Strides Arcolab said US market for the oral solution is estimated to be around USD 20 million annually.

Strides Arcolab shares were trading 1.63 per cent up at Rs 1,221.95 per scrip during afternoon session on the BSE.