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InnoPharma, Inc., Announces U.S. FDA Approval of Acetylcysteine Solution, USP, 20% for Inhalation or Oral Administration
Date:9/19/2012

PISCATAWAY, N.J., Sept. 19, 2012 /PRNewswire/ -- InnoPharma, Inc. today announced U.S. FDA approval of their Abbreviated New Drug Application (ANDA) for Acetylcysteine Solution, USP, a bronchial mucolytic indicated as an adjuvant therapy for patients with certain lung diseases and also as an acetaminophen antidote when administered orally. Acetylcysteine Solution, USP will be available in the coming weeks in 20% concentration for inhalation or oral administration in 30 ml vials. Acetylcysteine Solution, USP is currently on FDA's and ASHP's drug shortage lists.

InnoPharma has an agreement with Fresenius Kabi USA, LLC for its APP division to sell, market and distribute Acetylcysteine Solution, USP in the United States.

About Acetylcysteine Solution, USP, 20% Concentration in 30 ml Vials
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 (bronchograms, bronchospirometry and bronchial wedge catheterization)

Acetylcysteine, 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 InnoPharma, Inc.
InnoPharma is a sterile product development company, focused
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SOURCE InnoPharma, Inc.
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