InnoPharma, Inc. announced that the FDA has approved their Abbreviated New Drug Application (ANDA) for Acetylcysteine Solution, indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions.  Such conditions include chronic bronchopulmonary disease, acute bronchopulmonary disease, pulmonary complications of cystic fibrosis, tracheostomy care, pulmonary complications associated with surgery, use during anesthesia, post-traumatic chest conditions, atelectasis due to mucous obstruction, and diagnostic bronchial studies.

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

Acetylcysteine Solution will be available in the coming weeks as a 20% concentration for inhalation or oral administration in 30mL vials. Acetylcysteine Solution is currently on FDA’s and ASHP’s drug shortage lists.

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