The FDA has approved a supplemental New Drug Application (sNDA) for Cumberland Pharmaceuticals Inc.’s Acetadote (N-acetylcysteine for injection) product, an intravenous (IV) formulation of N-acetylcysteine (NAC) indicated to prevent or lessen liver injury after ingestion of potentially toxic quantities of acetaminophen.
 
Acetaminophen, a common over-the-counter pain reliever and fever reducer, is the leading cause of acute liver failure in the United States. Each year, thousands of individuals experience accidental or intentional acetaminophen poisoning, leading to serious liver damage.
 
The newly approved dosing regimen simplifies the administration of Acetadote by combining the first two bags of the standard regimen into a single, slower infusion. This streamlined approach has been implemented in hospitals across multiple countries and demonstrated to reduce the frequency of medication errors and potentially serious non-allergic anaphylactoid reactions (NAARs) without compromising the effectiveness of Acetadote2-6. By simplifying the dosing regimen, healthcare providers can administer the life-saving treatment more efficiently, potentially improving patient outcomes.
 
“We are thrilled to announce the FDA approval of this simplified dosing regimen for Acetadote,” said A.J. Kazimi, Cumberland’s Chief Executive Officer. “This important milestone underscores our commitment to improving patient care and providing innovative solutions for urgent medical needs. By streamlining the administration process, we aim to enhance patient outcomes and reduce the burden on health care providers.”