Navigation Links
Cumberland Pharmaceuticals Receives FDA Approval for New Formulation of Acetadote

NASHVILLE, Tenn., Jan. 13, 2011 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for a new formulation of Acetadote® (acetylcysteine) Injection, the Company's product used to treat acetaminophen poisoning. The proprietary new formulation, which does not contain Ethylene diamine tetracetic acid or any other stabilization and chelating agents and is free of preservatives, will replace the currently marketed product. Cumberland is immediately commencing U.S. launch activities for this next generation Acetadote product and will no longer manufacture the previously approved formulation.

Acetadote, which has been available in the United States since Cumberland's 2004 introduction of the product, is currently used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter pain relief and fever-reducing products. Acetaminophen continues to be the leading cause of poisonings reported by hospital emergency rooms in the United States, and Acetadote has become a standard of care for treating this potentially life-threatening condition.

"We are committed to further developing our products, whether to expand into new patient populations or to improve upon an existing formulation, and worked with the FDA to develop this new formulation of Acetadote," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We look forward to introducing this next generation product to the hospital community and the growing number of patients who will benefit from it."

The new formulation of Acetadote is the result of a phase IV commitment Cumberland made to the FDA upon receipt of initial marketing approval of the product. Cumberland initiated a program to develop the new formulation and determined that it could be prepared and scaled in a commercial manufacturing setting without compromising the potency, solubility or stability of the product. The Company obtained approval for an extended shelf life with the new product, up from 24 months for the original formulation to 30 months.

About Acetadote

Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is the only injectable product approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter painkillers. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. Serious anaphylactoid reactions, including death in a patient with asthma, have been reported in patients administered acetylcysteine intravenously. Acetadote should be used with caution in patients with asthma, or where there is a history of bronchospasm. The total volume administered should be adjusted for patients weighing less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed. If volume is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure, and death.  For full prescribing information, visit

About Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company's primary target markets include hospital acute care and gastroenterology. Cumberland's product portfolio includes Acetadote® (acetylcysteine) Injection for the treatment of acetaminophen poisoning, Caldolor® (ibuprofen) Injection, the first injectable treatment for pain and fever available in the United States, and Kristalose® (lactulose) for Oral Solution, a prescription laxative. Cumberland is dedicated to providing innovative products which improve quality of care for patients. For more information, please visit the company website at

Important Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that reflect Cumberland's current views with respect to future events, based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of operations are subject to influences outside of the Company's control. Risk factors that could materially affect results of operations include, among other things, market conditions, intense competition from existing and new products, an inability of manufacturers to produce Acetadote on a timely basis or a failure of manufacturers to comply with stringent regulations applicable to drug manufacturers, maintaining and building an effective sales and marketing infrastructure, government regulation, the possibility that marketing exclusivity and patent rights may provide only limited protection from competition, and other factors related to the Company including those under the headings "Risk factors" and "Management's discussion and analysis of financial condition and results of operations" in Cumberland's Form 10-K filed with the SEC on March 19, 2010. There can be no assurance that the results or developments anticipated by Cumberland will be realized or, if realized, that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. Cumberland undertakes no obligation to release publicly any revisions to these statements to reflect events or circumstances after the date hereof.

SOURCE Cumberland Pharmaceuticals Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Cumberland Pharmaceuticals Announces Joey Jacobs Has Joined Its Board of Directors
2. Cumberland Pharmaceuticals Announces Voluntary Recall of Acetadote® Vials
3. Cumberland Pharmaceuticals Reports Third Quarter 2010 Financial Results
4. Cumberland Pharmaceuticals to Announce Third Quarter 2010 Financial Results on November 11, 2010
5. Cumberland Pharmaceuticals and Phebra Pty Ltd. Announce the Launch of Acetadote® in Australia
6. Cumberland Pharmaceuticals Announces Extension of FDA Review of Acetadote® Supplemental New Drug Application
7. Cumberland Pharmaceuticals Reports Second Quarter 2010 Financial Results
8. Cumberland Pharmaceuticals to Present at the Wells Fargo Healthcare Conference in Boston on June 23, 2010
9. Cumberland Pharmaceuticals to Present at Jefferies Global Life Sciences Conference in New York on June 8, 2010
10. Cumberland Pharmaceuticals To Announce First Quarter 2010 Financial Results on May 13, 2010
11. Cumberland Pharmaceuticals Partners in Canada With Alveda Pharmaceuticals to Commercialize Caldolor(R)
Post Your Comments:
(Date:11/24/2015)... and BERN, Switzerland , ... the ARTORG Center for Biomedical Engineering Research of the ... the Division of Endocrinology, Diabetes and Clinical Nutrition of ... the start of an exclusive collaboration to develop a ... algorithm for the personalised delivery of insulin for diabetic ...
(Date:11/24/2015)... F1000Workspace - a research collaboration, reference management ... just six months ago. --> F1000Workspace - ... - since it was launched just six months ago. ... F1000Workspace - a research collaboration, reference management and ... six months ago. --> --> ...
(Date:11/24/2015)... 24, 2015  Figure 1, a free mobile-first network ... cases, has launched a new completely redesigned web version ... allows radiologists, who work primarily on a desktop, to ... with its radiologist user base, Figure 1 is hosting ... North America (RSNA) Annual Meeting. ...
Breaking Medicine Technology:
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... Dr. Rodney E. Willey , has ... new venture, Koala Center for Sleep Disorders, provides treatment for snoring and sleep apnea ... have opened a Koala Center for Sleep Disorders in the US, one of four in ...
(Date:11/24/2015)... ... November 24, 2015 , ... American Specialty Health Fitness, ... have announced their endorsement of the Medical Fitness Network (MFN), a national health ... have the MFN as one of our endorsed organizations,” said ASH Fitness Vice ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... Autism Speaks, ... the global movement driven by social media and the generosity of people around the ... encourage their social media networks to give – and share the personal stories behind ...
(Date:11/24/2015)... ... November 24, 2015 , ... World ... Innovative Blending, a household invention that revolutionizes the vending machine industry by providing ... market is worth $2 billion," says Scott Cooper, CEO and Creative Director of ...
(Date:11/24/2015)... ... , ... Robert Yeager CEO of PharmMD, has announced the release ... have been multiple breakthroughs and challenges as healthcare reform moves out of its infancy ... and partners to stay ahead of the curve by breaking down barriers for every ...
Breaking Medicine News(10 mins):