INNOPHARMA Announces FDA Approval of Acetylcysteine Solution, USP, 20% for Inhalation or Oral Administration
9/19/2012 7:12:47 AM
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 on developing niche generic and innovative specialty pharmaceutical products in injectable and ophthalmic dosage forms. The Company has a broad portfolio of products under development, with formulations including solutions, suspension, lyophilized, emulsions, liposomes, micelles and lipid complexes. InnoPharma's pipeline includes small molecules with solubility and stability challenges, as well as difficult to produce and characterize polypeptides and carbohydrates. The Company has a comprehensive infrastructure for the development of its products in its state of the art R&D facilities in New Jersey, with the capability to handle potent and cytotoxic molecules. More information can be found at www.innopharmainc.com.
About Fresenius Kabi
Fresenius Kabi is focused on the care of critically and chronically ill patients inside and outside the hospital. Its portfolio of products comprises a wide range of IV drugs, infusion therapies, clinical nutrition products as well as the related medical devices and blood transfusion technologies. With a corporate philosophy of "caring for life," the company's goal is to improve the patient's quality of life. Fresenius Kabi AG is a 100 percent subsidiary of the health care group Fresenius SE & Co. KGaA. For more information, visit www.fresenius-kabi.com.
In the United States, APP, a division of Fresenius Kabi USA, LLC develops, manufactures and markets injectable pharmaceutical products with a focus on the oncology, anti-infective, anesthetic/analgesic and critical care markets for use in hospitals, long-term care facilities, alternate care sites and clinics. For more information, visit www.APPpharma.com
SOURCE InnoPharma, Inc.