Navigation Links
Cumberland Pharmaceuticals Announces Extension of FDA Review of Acetadote® Supplemental New Drug Application

NASHVILLE, Tenn., Aug. 20 /PRNewswire-FirstCall/ -- Cumberland Pharmaceuticals Inc.(Nasdaq: CPIX) today announced the U.S. Food and Drug Administration (FDA) has extended its review of the supplemental new drug application (sNDA) for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. The review has been extended by three months resulting in a new Prescription Drug User Fee Act (PDUFA) goal date in December 2010.

"We look forward to continued discussion with the FDA regarding this potentially life-saving treatment for patients who have few alternatives," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals.

Acute liver failure is a rare syndrome associated with a high mortality rate and frequent need for liver transplantation. Approximately 50 percent of acute liver failure cases are caused by acetaminophen poisoning. Other causes of acute liver failure not induced by acetaminophen overdose include hepatitis B disease, autoimmune hepatitis, Wilson disease, fatty liver of pregnancy, and HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome. Currently, transplantation of the liver is the only treatment for patients with liver failure not caused by acetaminophen overdose. In March 2010, Cumberland submitted the sNDA to the FDA for the use of Acetadote in patients with non-acetaminophen acute liver failure. The FDA formally accepted the application for review and designated the review classification as Priority in May 2010.

Acetadote was launched by Cumberland in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose. In 2006, the FDA approved Acetadote for use in pediatric patients. The Company also received FDA approval for updated labeling regarding the safety of Acetadote in 2008 based on new information from a post-marketing safety study reporting a lower-incidence of side effects compared to previously reported data.

About Acetadote Acetadote® (acetylcysteine) Injection is used in the emergency department to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter painkillers. It is the only approved injectable product in the United States for the treatment of acetaminophen overdose. 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 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 and Kristalose® (lactulose) for Oral Solution, a prescription laxative. The Company also recently launched Caldolor® (ibuprofen) Injection, the first injectable treatment for pain and fever approved in the United States. Cumberland is dedicated to providing innovative products which improve quality of care for patients. The Company completed the initial public offering of its common stock in August 2009. For more information on Cumberland Pharmaceuticals, please visit

Important Note Regarding Forward-Looking StatementsThis 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 others, those factors discussed in Cumberland's Registration Statement declared effective by the SEC on August 10, 2009. There can be no assurance that results or developments anticipated by Cumberland will be realized or, even if realized, that they will have the expected effects. Readers are cautioned not to place undue reliance on these 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 or to reflect the occurrence of unanticipated events. Investor Contact:Angela NovakCumberland Pharmaceuticals615-255-0068investors@cumberlandpharma.comMedia Contact:Rebecca KirkhamLovell

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

Related medicine technology :

1. Cumberland Pharmaceuticals to Announce Third Quarter 2009 Financial Results on November 10, 2009
2. Cumberland Pharmaceuticals and Phebra Pty Ltd. Sign Exclusive Agreement for Commercialization of Caldolor(R) in Australia and New Zealand
3. Cumberland Pharmaceuticals Donates Caldolor(R) to Haitian Relief Effort
4. Cumberland Pharmaceuticals Reports 24% Increase in Net Revenue With Full Year 2009 Financial Results
5. Cumberland Pharmaceuticals Partners in Canada With Alveda Pharmaceuticals to Commercialize Caldolor(R)
6. Cumberland Pharmaceuticals To Announce First Quarter 2010 Financial Results on May 13, 2010
7. Cumberland Pharmaceuticals to Present at Jefferies Global Life Sciences Conference in New York on June 8, 2010
8. Cumberland Pharmaceuticals to Present at the Wells Fargo Healthcare Conference in Boston on June 23, 2010
9. Cumberland Pharmaceuticals Reports Second Quarter 2010 Financial Results
10. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
11. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
Post Your Comments:
(Date:10/4/2017)... Oct. 4, 2017 OBP Medical ... illuminating medical devices, today announced regulatory approval from ... Agency (or Agência Nacional de Vigilância Sanitária (ANVISA)) ... cordless surgical retractor with integrated LED light source ... illumination and exposure of a tissue pocket or ...
(Date:10/2/2017)... announces the European launch of their new low volume, high throughput ... Cambridge, U.K on October 4th. The new ... unprecedented speed and sensitivity while using far less sample volume through ... ... ...
(Date:9/27/2017)... 27, 2017  Commended for their devotion to personalized service, ... as number one in the South Florida Business Journal,s 50 ... 5000 yearly list, the national specialty pharmacy has found its ... will soon be honored by SFBJ as the 2017 ... Set to receive his award in October, Bardisa said ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a ... utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will revolutionize the ... a CBD form that can be easily incorporated into liquid products, while reducing costs ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , ... mock evacuation of the facility as part of a disaster drill on October 3rd. ... EMS and Shelton City Emergency Manager, as well as the Connecticut Long Term ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional women, ... towards gender equality at their inaugural Summit in New York City in June. The ... social audience of over 3 million. To watch the Mobilize Women video, click ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... viewers the lowdown on sciatica in a new episode of "Success Files," which ... current events and innovation and investigates each subject in-depth with passion and integrity. ...
(Date:10/13/2017)... ... ... “America On The Brink”: the Christian history of the United States and the loss ... author, William Nowers. Captain Nowers and his wife, Millie, have six children, ten ... the Navy. Following his career as a naval aviator and carrier pilot, he ...
Breaking Medicine News(10 mins):