January 14, 2011
FDA approves new formulation of AcetadoteThe FDA has approved a new formulation of Acetadote (acetylcysteine injection, from Cumberland) which does not contain ethylene diamine tetracetic acid or any other stabilization and chelating agents, and is preservative-free. Cumberland has begun launch activities for the new formulation of Acetadote and will no longer manufacture the previously approved formulation. The new formulation is also approved with an extended shelf life of 30 months, compared to 24 months with the original formulation.
Acetadote is indicated to minimize hepatic injury after acetaminophen overdose. The FDA recently issued a statement asking manufacturers of acetaminophen-containing prescription combination products to limit the amount of APAP in their products in order to reduce the risk of severe liver injury.
For more information call (866) 767-5077 or visit www.acetadote.net.