"InnoPharma is dedicated to developing complex generic and innovative specialty pharmaceutical drug products in a high quality, time efficient and cost effective manner. For us, providing value add to patients, prescribers and distributors is at the core of our business model."
InnoPharma, Inc., Announces U.S. FDA Approval of Acetylcysteine Solution, USP, 20% for Inhalation or Oral Administration
September 19, 2012
PISCATAWAY, N.J., September 19, 2012 -- 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. Acethylcysteine 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.
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,
• 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.
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
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 .
Innopharma is proud to announce that we were awarded a grant under NJ Business Employment and Incentive Program (BEIP), designed for companies that are poised to create jobs in the state of New Jersey.
Additional information on the BEIP grants can be found at www.njeda.com/beip