FDA approves InnoPharma Acetylcysteine Solution, USP, 20%

Acetylcysteine Solution, USP, is a bronchial mucolytic indicated as an adjuvant therapy for patients with certain lung diseases and also as an acetaminophen antidote when administered orally.

The company plans to launch the product shortly in 20% concentration for inhalation or oral administration in 30ml vials.

Fresenius Kabi USA will sell, market and distribute Acetylcysteine Solution, USP in the US under an existing contract with InnoPharma.

Acetylcysteine Solution, USP, is indicated as adjuvant therapy for patients with abnormal, viscid or inspissated mucous secretions in chronic bronchopulmonary disease, acute bronchopulmonary disease, pulmonary complications of cystic fibrosis, tracheostomy care, pulmonary complications, post-traumatic chest conditions and so on.

Acetylcysteine, administered orally, is indicated as an antidote to prevent or lessen hepatic injury that occurs following the ingestion of a potentially hepatotoxic quantity of acetaminophen.