Cumberland Pharmaceuticals Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for a new formulation of Acetadote® (acetylcysteine) Injection, the Company's product used to treat acetaminophen poisoning. The proprietary new formulation, which does not contain Ethylene diamine tetracetic acid or any other stabilization and chelating agents and is free of preservatives, will replace the currently marketed product. Cumberland is immediately commencing U.S. launch activities for this next generation Acetadote product and will no longer manufacture the previously approved formulation.
Acetadote, which has been available in the United States since Cumberland's 2004 introduction of the product, is currently used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter pain relief and fever-reducing products. Acetaminophen continues to be the leading cause of poisonings reported by hospital emergency rooms in the United States, and Acetadote has become a standard of care for treating this potentially life-threatening condition.
"We are committed to further developing our products, whether to expand into new patient populations or to improve upon an existing formulation, and worked with the FDA to develop this new formulation of Acetadote," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We look forward to introducing this next generation product to the hospital community and the growing number of patients who will benefit from it."
The new formulation of Acetadote is the result of a phase IV commitment Cumberland made to the FDA upon receipt of initial marketing approval of the product. Cumberland initiated a program to develop the new formulation and determined that it could be prepared and scaled in a commercial manufacturing setting without compromising the potency, solubility or stability of the product. The Company obtained approval for an extended shelf life with the new product, up from 24 months for the original formulation to 30 months.
Cumberland Pharmaceuticals Inc.