PISCATAWAY, N.J., Jan. 8, 2013 /PRNewswire/ -- InnoPharma, Inc. today announced U.S. FDA approval of its Abbreviated New Drug Application (ANDA) for acetylcysteine injection, indicated to prevent or lessen hepatic injury following an acetaminophen overdose. Acetylcysteine injection will be available as a 20% solution (200mg/mL) in 30mL single-dose glass vials. Acetylcysteine injection is sterile and can be used for I.V. administration.
InnoPharma has an agreement with Fresenius Kabi USA, LLC for its APP division to sell, market and distribute acetylcysteine injection in the United States. InnoPharma has received 180 days of generic drug exclusivity from FDA for its ANDA.
Navneet Puri, Ph.D., president & CEO of InnoPharma noted, “This ANDA approval provides the first generic alternative to Acetadote® injection, and continues to demonstrate InnoPharma’s commitment to provide options to health care providers and patients.”
About InnoPharma, Inc.
InnoPharma is a private sterile product development company, focused on developing complex 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.
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, some of which are outside management’s control, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. These risks, trends and uncertainties are in some instances beyond our control. Words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “will” and other similar expressions identify forward-looking statements, although not all forward-looking statements contain these identifying words. InnoPharma, Inc. undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
SOURCE InnoPharma, Inc.
