Healthcare Industry News:  Acetadote 

Biopharmaceuticals FDA

 News Release - March 6, 2006

Cumberland Pharmaceuticals Announces Updated Labeling for Acetadote(R)

New label provides direction for use in pediatric patients

NASHVILLE, Tenn., March 6 (HSMN NewsFeed) -- Cumberland Pharmaceuticals announced today it has received approval from the U.S. Food and Drug Administration (FDA) for revised labeling of Acetadote, the first injectable drug used to treat acetaminophen overdose in the U.S. The updated package insert provides important new dosing information for pediatric patients.

"We are extremely pleased to make this product available for use in treating children," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "Recent studies indicate that acetaminophen poisonings in the U.S. are on the rise, with up to 70 percent of reported exposures occurring in children under the age of 19. The new labeling provides important information for treatment of these overdose patients."

Acetadote (acetylcysteine) Injection is used in the emergency department to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter painkillers. The leading cause of poisonings presenting in emergency departments in the U.S., these overdoses account for more than 56,000 emergency room visits and 450 deaths each year.

Following the launch of the product in 2004, Acetadote is now stocked in 2,400 hospitals across the country. The revised label, which also includes a change in the duration of the loading dose from 15 to 60 minutes, can be found on the product web site at www.Acetadote.com.

"We continue to closely monitor use of our products to ensure we are providing physicians and healthcare professionals with the information they need to make informed treatment decisions," said Kazimi.

Cumberland Pharmaceuticals Inc. is a Tennessee based specialty pharmaceutical company that develops and markets niche pharmaceutical products for specific physician segments, including critical care, emergency medicine and gastroenterology. Cumberland is dedicated to providing high quality products, which fill unmet medical needs. For more information, please visit the Cumberland Pharmaceuticals web site at www.cumberlandpharma.com.


Source: Cumberland Pharmaceuticals

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