Navigation Links
InnoPharma, Inc., Announces U.S. FDA Approval of Acetylcysteine Solution, USP, 20% for Inhalation or Oral Administration

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

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

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

SOURCE InnoPharma, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. A New Audio Interview With Ronald Adams President Of Medical Alarm Concepts Holding, Inc., Is Now At
2. Aperture Health, Inc., Targeting the Strong Growth in the Long Term Disease Management arena
3. Trovagene, Inc., Announces Issuance of U.S. Patent for NPM Mutants to Diagnose and Monitor Acute Myeloid Leukemia
4. Empire Asset Management Co. Initiates Coverage on Transcept Pharmaceuticals Inc., (NASDAQ: TSPT)
5. Huntzinger Management Group, Inc., (HMG) Reporting Significant Growth in 2012
6. Intrepid Investment Bankers LLC Advises A-Med Health Care in the Sale of its Specialty Pharmacy Assets to Modern HC Pharmacy, Inc., a portfolio company of Altamont Capital Partners
7. Fetal Surveillance Company, PeriGen, Inc., to Collaborate with National Institute of Child Health and Human Development to Research Fetal Heart Rate Patterns During Labor
8. Groupe Athena Inc., (OTC: GATA) Reports Audited Financials, Announces Record Revenue & Profits
9. Cempra, Inc., to Present at 2012 Stifel Nicolaus Healthcare Conference and NewsMakers in the Biotech Industry Conference
10. Perrigo Company To Acquire Assets Of Sergeants Pet Care Products, Inc., For $285 Million
11. Precision Optics Corporation Announces $1 Million Order for Microprecision™ Based Endoscopes
Post Your Comments:
(Date:11/27/2015)... 2015  Lannett Company, Inc. (NYSE: LCI ... acquisition of Kremers Urban Pharmaceuticals Inc. (KU), the ... company UCB S.A. (Euronext: UCB). ... KU from UCB for total consideration of approximately ... customary working capital adjustment, a deduction of certain ...
(Date:11/27/2015)... 26, 2015 ... the "2016 Global Tumor Marker Testing ... and Sales Segment Forecasts, Innovative Technologies, Instrumentation ... to their offering. --> ... "2016 Global Tumor Marker Testing Market: ...
(Date:11/26/2015)... Un nuevo enfoque combina la ... cáncer avanzado.   --> Un nuevo ... Bremachlorin para el cáncer avanzado.   --> ... la terapia fotodinámica de Bremachlorin para el cáncer avanzado. ... --> Clinical Cancer Research . --> ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... 2015 , ... An inventor, from Hopkinsville, Ky., thought there ... home, so he invented the patent-pending ELECTRONIC M.D. , The ELECTRONIC M.D. provides ... so, it could help to prevent potential overdose situations. As a result, it ...
(Date:11/27/2015)... Aliso Viejo, CA (PRWEB) , ... November 27, 2015 , ... ... exclusively for use in Final Cut Pro X. With ProSidebar: Fasion, video editors ... banners, or use ProSidebar as a minimalist title opener. Utilize presets featuring self-animating ...
(Date:11/27/2015)... ... November 27, 2015 , ... A simply groundbreaking television ... an interesting show that delves into an array of issues that are presently affecting ... benefit from open dialogue, this show is changing the subjects consumers focus on, one ...
(Date:11/27/2015)... ... November 27, 2015 , ... The men and ... nonprofit healthcare organizations in the country. They have overseen financial turnarounds, shown commitment ... advance the healthcare industry as a whole through their advocacy and professional efforts. ...
(Date:11/26/2015)... ... November 26, 2015 , ... Patients at Serenity Point ... come together on Thanksgiving Day to share the things that they are most ... Serenity Point YouTube channel, patients displayed what they wrote on index cards, describing ...
Breaking Medicine News(10 mins):