Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

FDA Approves Colonoscopy Prescription Preparation

By Pharmaceutical Processing | May 24, 2004

BRAINTREE, MA (May 24, 2004) – Braintree Laboratories, Inc. announced that the U.S. Food & Drug Administration has approved the HalfLytely and Bisacodyl Tablets Bowel Prep Kit (peg-3350, sodium chloride, sodium bicarbonate, potassium chloride for oral solution and bisacodyl delayed release tablets) as a prescription preparation for bowel cleansing prior to colonoscopy.

HalfLytely enables patients to ingest half the volume of solution traditionally required with a significant reduction in bowel-prep related discomfort, according to Braintree.

The HalfLytely and Bisacodyl Tablets Bowel Prep Kit also maintains efficacy comparable to the category-leading NuLytely (PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution), the company said.

“The arrival of a more tolerable bowel prep is crucial because the cramping, nausea and fullness associated with traditional prep is a major reason that people avoid having a colonoscopy,” said Dr. Jack A. DiPalma, medical director for Braintree. “Almost 90 percent of nearly 60,000 colon cancer deaths in the United States this year could have been prevented if diagnosed in the early stages through colonoscopy.” DiPalma is also vice president of the American College ofGastroenterology and director, division of Gastroenterology, University of South Alabama College of Medicine.

HalfLytely’s FDA approval is based on the agency’s review of safety and efficacy data from two U.S. Phase III clinical trials in a total of 400 patients, Braintree said.

Braintree expects HalfLytely to be available to physicians, patients, and pharmacies on Sept. 1, 2004. Braintree Laboratories is a privately held pharmaceutical company.

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE