Strides Arcolab Limited, a Rs. 1,000 crore plus pharma giant, has received approval from the United States Food & Drug Administration (FDA) for polyethylene glycol 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution, 420 grams/11.2 grams/5.72 grams/1.48 grams/4 litres.
According to IMS data, the US market for polyethylene glycol 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution is approximately USD 20 million.
The product will be manufactured at the company’s oral dosage facility at Bengaluru and marketed by Strides in the US market.
Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution is used for bowel cleansing prior to colonoscopy. Polyethylene glycol 3350 is an osmotic laxative, and along with the electrolytes, the combination is used in preparation for colonoscopy in adults and paediatric patients aged six months or greater.