Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Mylan Pharmaceuticals (Mylan) has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Polyethylene Glycol 3350 and Electrolytes for oral solution, USP, the generic version of Braintree Laboratories' GoLytely laxative. Mylan's version is available for immediate shipment.
Subscribe to our email newsletter
The polyethylene glycol (PEG) and electrolytes solution is used to clean the colon (large bowel or lower intestine) before certain tests or surgery of the colon. The PEG-electrolyte solution is usually taken by mouth. However, sometimes it is given in the hospital through a nasogastric tube (a tube inserted through the nose).
The PEG-electrolyte solution acts like a laxative. It causes liquid stools or mild diarrhea. In this way, it flushes all solid material from the colon, so the doctor can have a clear view.
Polyethylene glycol 3350 is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. Polyethylene glycol 3350 is used as a laxative to treat occasional constipation or irregular bowel movements.
Currently, Mylan has 141 ANDAs pending FDA approval.