Navigation Links
Cumberland Pharmaceuticals Receives FDA Approval for New Formulation of Acetadote
Date:1/13/2011

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 www.acetadote.net.

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 www.cumberlandpharma.com.

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:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... 2016  HemaFlo Therapeutics, Inc. announced today that the United ... Number 9,119,880 covering the use of NephroFlow to treat acute ... HemaFlo,s founder, said, "We are pleased to secure our rights ... Peterson , PhD, HemaFlo,s founder, said, "We are pleased to ... --> Dale Peterson , PhD, HemaFlo,s founder, said, ...
(Date:2/8/2016)... Feb. 8, 2016 Palatin Technologies, Inc. ... receptor-specific peptide therapeutics for the treatment of diseases ... announced today that the United States Patent and ... Allowance for U.S. Patent Application Serial Number 14/313,258 ... methods of treating female sexual dysfunction using the ...
(Date:2/5/2016)... , Feb. 5, 2016 Amgen (NASDAQ: AMGN ... Annual Global Healthcare Conference at 9:15 a.m. ET on Wednesday, ... . David W. Meline , executive vice president and ... Live audio of the presentation can be accessed from the ... A replay of the webcast will also be available on ...
Breaking Medicine Technology:
(Date:2/8/2016)... CA (PRWEB) , ... February 08, 2016 , ... Delta ... $792,000 to help combat pancreatic cancer. , Gary D. Radine, who recently retired as ... was the American Cancer Society’s 2015 CEO of the Year , helped lead ...
(Date:2/8/2016)... ... ... Discover the Rocky Mountain region’s longest running and impressive garden and home show where ... see the most incredible gardens and home improvement experts that attend this amazing show. ... - 700 14th St. Denver CO, is an exciting event that Performance Mobility has ...
(Date:2/8/2016)... ... , ... Guruji Mahendra Kumar Trivedi is offering 3 days of accelerated personal ... birthday on February 10th. During this time, people can achieve better health, greater ... people from over 40 different countries as an “ordinary man with an extraordinary gift.” ...
(Date:2/7/2016)... Dallas, Texas (PRWEB) , ... February 07, 2016 ... ... its new MyDecision™ program. MyDecision™ empowers employers and organizations with the tools and ... , MyDecision™ combines three elements to cut the cost of providing employee healthcare ...
(Date:2/6/2016)... (PRWEB) , ... February 06, 2016 , ... Shark ... to announce the launch of a new DRTV campaign with Belly Bands. , Having ... tried everything from sprays to puppy pads and find nothing works, get Belly ...
Breaking Medicine News(10 mins):