FDA APPROVES ACETADOTE® sNDA – News Directory 3

NASHVILLE, Tenn., Dec. 9, 2024 – Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a leading specialty pharmaceutical company, announced today that the FDA has approved a supplemental New Drug Application (sNDA) for its Acetadote (N-acetylcysteine for injection) product. This approval simplifies the governance of Acetadote, a crucial treatment for acetaminophen overdose, potentially improving patient outcomes and reducing the risk of adverse events.

Acetaminophen, a common over-the-counter pain reliever, 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 combines the first two bags of the standard Acetadote regimen into a single, slower infusion. This streamlined approach has been successfully implemented in hospitals worldwide and has been shown to reduce medication errors and potentially serious non-allergic anaphylactoid reactions (NAARs) without compromising the effectiveness of Acetadote.

“This FDA approval is a meaningful step forward in the treatment of acetaminophen overdose,” said Dr. Rick Dart, MD, PhD, Director at the Rocky Mountain Poison and Drug Center. “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.”

“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 critically 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.”

Key Highlights:

• FDA-approved sNDA adds a simplified, IV NAC dosing regimen to the product prescribing information.
• New IV NAC dosing regimen is both safe and effective.
• New dosing regimen aims to minimize interruptions in care, medication errors, and the incidence of dose-related reactions.

Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee. The company is focused on providing unique products that improve the quality of patient care. Cumberland develops, acquires, and commercializes products for the hospital acute care, gastroenterology, and oncology market segments.

The company’s portfolio of FDA-approved brands includes:

• Acetadote (acetylcysteine) injection, for the treatment of acetaminophen poisoning;
• Caldolor (ibuprofen) injection, for the treatment of pain and fever.

Nashville, TN – Cumberland Pharmaceuticals Inc. today announced the U.S. Food and Drug Administration (FDA) has approved four new products, expanding the company’s portfolio of critical care and specialty medications. These approvals mark a significant milestone for Cumberland, demonstrating its commitment to developing innovative treatments for unmet medical needs.

The newly approved medications include:

• Kristalose (lactulose) oral: A prescription laxative for the treatment of constipation.
• Sancuso (granisetron) transdermal: A patch designed to prevent nausea and vomiting in patients undergoing certain types of chemotherapy.
• Vaprisol (conivaptan) injection: An injectable medication used to increase sodium levels in hospitalized patients with specific types of low sodium conditions.
• Vibativ (telavancin) injection: An antibiotic for treating serious bacterial infections, including hospital-acquired and ventilator-associated pneumonia, as well as intricate skin and skin structure infections.

“We are thrilled to bring these important new therapies to patients and healthcare providers,” said a Cumberland Pharmaceuticals Executive. “These approvals reflect our dedication to research and advancement, and our unwavering focus on improving patient outcomes.”

In addition to these new approvals, Cumberland is actively engaged in Phase II clinical trials evaluating its ifetroban product candidate for the treatment of cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis, and Idiopathic Pulmonary Fibrosis.

About Cumberland Pharmaceuticals, it is a specialty pharmaceutical company focused on the development and commercialization of high-quality, patient-focused therapies. The company is dedicated to improving the lives of patients with unmet medical needs through innovative research and development.

This FDA approval underscores Cumberland Pharmaceuticals’ commitment to innovation and patient care. It represents a tangible step towards addressing a significant public health issue and offers hope to countless individuals at risk of acetaminophen overdose.