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news.Cumberland Pharmaceuticals and Phebra said that Acetadote (acetylcysteine) Injection, an injectable product used to treat acetaminophen (paracetamol) overdose, is now commercially available in the Australian market.
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Under the agreement between Cumberland and Phebra, Phebra is responsible for ongoing regulatory requirements, marketing, distribution and sales of Acetadote in Australia, New Zealand and the Asia Pacific.
Phebra has also obtained marketing approval in New Zealand and will continue to work toward obtaining approval for the Asia Pacific markets.
Cumberland maintains responsibility for product formulation, development and manufacturing, and for providing Phebra with finished product, labeled and packaged for its specific territories.
In exchange for the product license, Cumberland receives upfront and milestone payments, a transfer price and royalties on future sales.
Phebra CEO and president Mal Eutick said that paracetamol poisoning is an extremely serious overdose which, if not timely and accurately treated, can be life-threatening.
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 US to treat overdose of acetaminophen, a common ingredient in many over-the-counter painkillers, Cumberland said.