Navigation Links
Acetadote(R) Approved in Australia for Treatment of Acetaminophen Poisoning
Date:5/11/2010

NASHVILLE, Tenn., May 11 /PRNewswire-FirstCall/ -- Cumberland Pharmaceuticals Inc. ( CPIX) and Phebra Pty Ltd. today announced that Acetadote® (acetylcysteine) Injection has been granted regulatory approval for marketing and sale in Australia. Acetadote, an injectable drug used to treat acetaminophen (paracetamol) overdose, was approved by the Therapeutic Goods Administration (TGA), the government agency responsible for regulating drugs and medical devices in Australia.

U.S.-based Cumberland Pharmaceuticals has granted an exclusive license to Phebra Pty Ltd., an Australian-based specialty pharmaceutical company, for commercialization of Acetadote in Australia. Phebra is now preparing for the Australian launch of the product, which it expects to commence in the coming weeks.

"We are delighted to obtain TGA approval for Acetadote and to make this product available to Australian hospitals," said Dr. Mal Eutick, President and Chief Executive Officer of Phebra. "We believe that using Acetadote to treat paracetamol poisoning offers a significant clinical benefit for patients and their caregivers in comparison to alternative courses of treatment, and look forward to communicating the product's benefits to the Australian medical community."

Acetadote is 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. Since Cumberland Pharmaceuticals' U.S. introduction of the product in 2004, Acetadote has become a standard of care for treating acetaminophen poisoning.

Under their agreement, Phebra is responsible for ongoing regulatory requirements, marketing, distribution and sales of Acetadote in Australia, New Zealand and the Asia Pacific while Cumberland maintains responsibility for product formulation, development and manufacturing. In exchange for the product license, Cumberland receives upfront and milestone payments, a transfer price and royalties on future sales.

"Cumberland looks forward to working with Phebra to leverage their established distribution network and hospital marketing experience to make this life-saving drug available to a broader audience," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We believe Acetadote will provide an important treatment alternative for patients in the Australian market."

About Acetadote

Acetadote® (acetylcysteine) Injection is used in the emergency department to prevent or lessen potential liver damage resulting from an overdose of acetaminophen (paracetamol), 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 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 on Cumberland Pharmaceuticals, please visit the company website at www.cumberlandpharma.com.

About Phebra

Phebra Pty Ltd. is an Australian based specialty pharmaceutical company that develops and markets critical medicines in Australia, New Zealand, Asia, Canada and parts of Europe. For more information about Phebra please refer to the company website at www.phebra.com.

Important Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that reflect Cumberland's and Phebra's current views with respect to future events, based on what they believe are reasonable assumptions. No assurance can be given, however, that these events will occur. As with any business, all phases of operations are subject to influences outside of the companies' 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 pharmaceutical 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 companies, including those set forth 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 and Phebra will be realized or, even if substantially 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 and Phebra undertake no obligation to release publicly any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.


'/>"/>
SOURCE Cumberland Pharmaceuticals Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Cumberland Pharmaceuticals Provides Hospital In-Service Webcast for Acetadote(R)
2. ASP Sterrad Technology Approved by AFSSAPS for Total Inactivation of Prions
3. China YCT International Group, Inc. Announces That the State Intellectual Property Office of the Peoples Republic of China has Approved a Patent to its Operating Subsidiary, Shandong Spring Pharmaceutical Co. Ltd.
4. YM BIOSCIENCES OFFER FOR CYTOPIA APPROVED TO PROCEED TO SHAREHOLDER VOTE BY AUSTRALIAN COURT
5. BYETTA Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes
6. Recently Approved Onglyza Is Covered by 44 Percent of Commercial Health Plans But Less Than One Percent of Medicare Plans for The Treatment of Type 2 Diabetes
7. Accredited Construct Specific PCR Test for Recently Detected Unapproved GM Flax/Linseed FP967/CDC Triffid Available Through Genetic ID
8. YM BIOSCIENCES REPORTS NIMOTUZUMAB APPROVED FOR MARKETING IN MEXICO
9. American Scientific Resources To Be Exclusive Seller of Worlds Only FDA Approved Home Needle Destruction Device
10. Sumavel(TM) DosePro(TM) (sumatriptan injection) Approved by FDA for Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro Needle-Free Delivery System
11. REMERON(R) Now Approved in Japan for the Treatment of Depression in Adult Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... NEW YORK , Feb. 23, 2017 /PRNewswire/ ... leading digital health company, and Digital Noema ... and remote patient monitoring, announce they are partnering ... DN Telehealth maximizes collaboration compatibility for ... consultations beyond a physical clinical setting to include ...
(Date:2/23/2017)... ... 23, 2017 , ... BellBrook Labs is formalizing a significant ... of biochemical analyses critical for Lead Discovery. The company’s Lead Discovery Services ... including inhibitor potency and selectivity, mechanism of action, and inhibitor residence times on ...
(Date:2/23/2017)... , Feb. 23, 2017  MIODx announced today ... two key immunotherapy technologies from the University of ... a method to monitor a patient for response ... and CTLA-4.  The second license extends the technology ... is likely to have an immune-related adverse event ...
(Date:2/23/2017)... Feb. 23, 2017  Seattle,s upscale Capitol Hill neighborhood, with its ... place for a head lice treatment salon to set up ... Tuscan restaurant and a French bistro on E Madison Ave, ... aren,t just any old lice clinic, we pride ourselves on ... and release some of the stigma associated with lice. Everyone ...
Breaking Biology Technology:
(Date:2/13/2017)...  RSA Conference -- RSA, a Dell Technologies business, ... enhance fraud detection and investigation across digital environments ... & Risk Intelligence Suite. The new platform is ... from internal and external sources as well as ... from targeted cybercrime attacks. "Fraudsters are ...
(Date:2/10/2017)... -- Research and Markets has announced the ... Scientific and Commercial Aspects" to their offering. ... Biomarkers play ... therapy for selection of treatment as well for monitoring the ... disease in modern medicine. Biochip/microarray technologies and next generation sequencing ...
(Date:2/8/2017)... , Feb. 8, 2017 About Voice Recognition ... to match it against a stored voiceprint template. ... pitch, cadence, and tone are compared to distinguish ... hardware installation, as most PCs already have a ... transactions. Voice recognition biometrics are most likely to ...
Breaking Biology News(10 mins):