sNDA for Acetadote Approved by FDA

December 10, 2024

DENVER, Colo., Dec 10, 2024 (247marketnews.com)- Cumberland Pharmaceuticals (NASDAQ: CPIX) reported that the FDA approved a supplemental New Drug Application (sNDA) for its Acetadote (N-acetylcysteine for injection) product. Acetadote is an intravenous (IV) formulation of N-acetylcysteine (NAC) indicated to prevent or lessen liver injury after ingestion of potentially toxic quantities of acetaminophen, a common over-the-counter pain reliever and fever reducer that is the leading cause of acute liver failure in the United States.

The newly approved dosing regimen, which has been implemented in hospitals across multiple countries, has demonstrated to reduce the frequency of medication errors and potentially serious non-allergic anaphylactoid reactions (NAARs) without compromising the effectiveness of Acetadote.

Rick Dart, MD, PhD, Director at the Rocky Mountain Poison and Drug Center, commented, “This FDA approval is a significant step forward in the treatment of acetaminophen overdose. By streamlining the administration of NAC, we can improve patient outcomes and reduce the risk of adverse events. This simplified dosing regimen is a valuable tool for health care providers in managing this potentially life-threatening condition.”

A.J. Kazimi, Cumberland’s CEO, added, “We are thrilled to announce the FDA approval of this simplified dosing regimen for Acetadote. 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.”

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