Przybyl, president and CEO of ANI Pharmaceuticals said,"We are pleased to have received FDA approval of our ANDA for
Polyethylene Glycol 3350 powder for oral solution, bringing our total internal and partnered ANDA approvals for 2015 to three."
Efficacy and optimal dose of daily
polyethylene glycol 3350 for treatment of constipation and encopresis in children.
SCHERING-PLOUGH'S MIRALAX DEBUTS AS O-T-C: The first Rx-to-O-T-C switch in the laxative category in 30 years occurred this spring when MiraLAX (
polyethylene glycol 3350) moved to the O-T-C aisle.
Pediatric constipation therapy using guidelines and
polyethylene glycol 3350. Ann Pharmacother 2004; 38: 686-693.
He does not use
polyethylene glycol 3350 for oral solution because of the volume that must be consumed.
Electrolyte free
polyethylene glycol 3350 (PEG 3350), marketed in the United States under the brand name MiraLax (Braintree Laboratories, Braintree, MA), is a relatively new laxative that may be helpful in both the disimpaction and the treatment of constipation in children.
He reported on 37 children with constipation of more than 3 months who participated in an unblinded randomized crossover trial involving 2 weeks of lactulose at 1.3 g/kg per day divided into two doses, or
polyethylene glycol 3350 (PEG 3350) at 10 g/m2 per day, followed by 2 weeks of the other laxative.
Food and Drug Administration (FDA) has approved PLENVU(R) (
polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution), a lower-volume (1L) polyethylene glycol based (PEG) bowel preparation.
Mylan received final approval for its abbreviated new drug application for
polyethylene glycol 3350 and electrolytes for oral solution, a generic version of Braintree Laboratories' GoLytely laxative.
The good news is that with the wider availability and acceptance of
polyethylene glycol 3350, the treatment of stool retainers has become easier for parents, patients, and practitioners.
M2 EQUITYBITES-December 18, 2015-ANI Pharmaceuticals passes US FDA approval of
Polyethylene Glycol 3350 Powder for Oral Solution, 17mg/Scoopful for occasional constipation
M2 PHARMA-December 18, 2015-ANI Pharmaceuticals passes US FDA approval of
Polyethylene Glycol 3350 Powder for Oral Solution, 17mg/Scoopful for occasional constipation
