PISCATAWAY, N.J., -- 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.
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