The marketing and sale of the antidote for acetaminophen poisoning through, Acetadote (R) Injection has been approved in Australia, announced Cumberland Pharmaceuticals Inc. (CPIX) and Phebra Pty Ltd.
Acetadote is an injectable drug which is used in the treatment of acetaminophen (paracetamol) overdose, has been approved by the Therapeutic Goods Administration (TGA).
Exclusive license has been granted to the Phebra Pty Ltd., an Australian-based pharmaceultical company, by the US-based CPIX, for the marketing of the drug in Australia.
Phebra is currently working for the Australian launch of the product, that is expected to take place in the coming weeks.
Dr Mal Eutick, president and chief executive officer of Phebra is delighted that the drug will be made available for the use of the Australian hospitals.
We are delighted to obtain TGA approval for Acetadote and to make this product available to Australian hospitals.
We believe that using Acetadote to treat paracetamol poisoning offers a significant clinical benefit for patients and their caregivers in comparison to alternatve courses of treatment, and look forward to communicating the product's benefits to the Australian medical community, said Dr Eutick.
Introduction of the antidote in 2004 was made by the Cumberland Pharmaceuticals in the US, which has made Acetadote the standard treatment for patients experiencing acetaminophen overdose.
The drug will be used in hospitals Australia-wide to reduce or prevent potential liver damage triggered by an overdose of acetaminophen, a key ingredient in a number of pain relief and fever control medicine sold over-the-counter.
Phebra will be responsible for the regulation, distribution, marketing and sales of the product in Australia, New Zealand and the Asia Pacific, while CPIX holds the responsibility of the formulation, development and manufacturing of Acetadote.
Chief executive officer of the Cumberland Pharmaceuticals, A.J. Kazimi said, We believe Acetadote will provide and important treatment alternative for patients in the Australian market.