Fresenius Kabi Announces Availability of Acetylcysteine Solution, USP

Therapy to Treat Lung Diseases and Acetaminophen Overdose Available After Ongoing Shortage

October 1, 2012

SCHAUMBURG, Ill., October 1, 2012 – Fresenius Kabi USA today announced the launch of Acetylcysteine Solution, USP, 20% 30 mL vial for inhalation (mucolytic agent) or oral administration (acetaminophen antidote). For inhalation, it is used as adjuvant therapy for patients with certain lung diseases including chronic and acute bronchopulmonary disease. Inhalation therapy reduces the viscosity of mucus, thinning mucus secretions. When administered orally, it is used to prevent or lessen hepatic injury following acetaminophen overdose.

"The introduction of Acetylcysteine Solution further illustrates Fresenius Kabi's commitment to meeting market needs in the short term, while broadening the availability of our APP critical care products for the long term," said John Ducker, president and chief executive officer of Fresenius Kabi USA.

Acetylcysteine Solution, USP, has been on the US Food and Drug Administration's (FDA) and the American Society of Health-System Pharmacists' drug shortage lists since 2011. The launch of Acetylcysteine Solution, USP, should help mitigate the drug shortage for this critical product.

Acetylcysteine Solution, USP, was developed by InnoPharma, Inc., and the Abbreviated New Drug Application was approved by the FDA earlier this year. Fresenius Kabi has a licensing agreement with InnoPharma to sell, market and distribute Acetylcysteine Solution, USP, in the United States.

About Acetylcysteine Solution, USP, 20% Concentration in 30 ml

Acetylcysteine Solution, USP, is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as:

  • Chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung)
  • Acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis)
  • Pulmonary complications of cystic fibrosis
  • Tracheostomy care
  • Pulmonary complications associated with surgery
  • Use during anesthesia
  • Post-traumatic chest conditions
  • Atelectasis due to mucous obstruction
  • Diagnostic bronchial studies (bronchgrams, bronchospirometry, and bronchial wedge catheterization)

Acetylcysteine Solution, USP administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen.

About Fresenius Kabi

Fresenius Kabi is focused on the care of critically and chronically ill patients inside and outside the hospital. Its portfolio of products comprises a wide range of IV drugs, infusion therapies, clinical nutrition products as well as the related medical devices and blood transfusion technologies. With a corporate philosophy of "Caring for Life," the company's goal is to improve the patient's quality of life. Fresenius Kabi AG is a 100 percent subsidiary of the health care group Fresenius SE & Co. KGaA. For more information, visit

In the United States, APP, a division of Fresenius Kabi USA markets a broad portfolio of specialty pharmaceutical products with a focus on the oncology, anti-infective, anesthetic/analgesic and critical care markets for use in hospitals, long-term care facilities, alternate care sites and clinics. For more information, visit

Forward-Looking Statement

The statements contained in this news release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this news release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the demand, supply and distribution of our products. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, but are not limited to, the availability and pricing of ingredients used in the manufacture of pharmaceutical products and the ability to successfully manufacture products in a time-sensitive and cost effective manner. Additional relevant information concerning risks can be found in the Fresenius Kabi Pharmaceuticals Holding, Inc. 10-K for the fiscal year ending December 31, 2010 and other documents the company has filed with the Securities and Exchange Commission. The information contained in this news release is as of the date of this release. Fresenius Kabi Pharmaceuticals Holding, Inc. does not assume any obligation to update or revise these forward-looking statements to conform the statement to actual results, new information, developments or changes in the Company's expectations.

APP Contact
Matt Kuhn
Senior Director, Communications & Government Affairs
Fresenius Kabi USA