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FDA Approves Bronchial Mucolytic for Patients With Lung Diseases

Drug is formulated for inhalation or oral administration (Sept. 19)

InnoPharma, Inc., based in Piscataway, N.J., announced on September 19 that the FDA has approved the company’s 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 a 20% concentration for inhalation or oral administration in 30-mL vials.

The medicine is currently on the FDA's drug shortage list.

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, and 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 that may occur after the ingestion of a potentially hepatotoxic quantity of acetaminophen.

For more information, visit the InnoPharma, Inc. Web site.

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