Strides receives ANDA approval from USFDA

approved-green

(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.

Leave a Reply Sign in

Notify me of follow-up comments via e-mail address

Post Comment

Survey Box

Union Budget

Has Union budget 2017 addressed all requirements of healthcare industry?

Send this article by email

X