Strides receives ANDA approval from USFDA
April 16, 2015 | Thursday | News | By BioSpectrum Bureau
Strides receives ANDA approval from USFDA
(Photo Courtesy: www.tryitlocal.com)
Strides Arcolab announced that it has received approval from the United States Food & Drug Administration (USFDA) 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 liters.
It 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 pediatric patients aged six months or greater.
The product will be manufactured at the company's Oral dosage facility at Bangalore and marketed by Strides in the US market.
