MONMOUTH JUNCTION, N.J., Feb. 2 /PRNewswire/ — INNOPHARMA LLC announced today FDA approval of the Abbreviated New Drug Application (ANDA) for ibutilide fumarate injection (the generic equivalent of Corvert® from Pfizer Inc).
As the developer of this generic injectable drug, INNOPHARMA entered into a license agreement with Bioniche Pharma USA for marketing and product distribution of the injection product. Ibutilide fumarate injection represents INNOPHARMA’s first approved drug in their product pipeline.
Please refer to the Bioniche Pharma website to be directed to the complete prescribing information for this product, including the boxed warning.
INNOPHARMA is a research and development company, focused on developing niche generic and specialty pharmaceutical products. Through a business model of internal product development and commercialization licensure, INNOPHARMA has a comprehensive infrastructure for development of parenteral pharmaceutical products at its New Jersey facilities. INNOPHARMA works with manufacturing and clinical research organizations worldwide for commercialization of its developed products. More information about INNOPHARMA can be found at www.innopharmallc.com.
About Bioniche Pharma:
Bioniche Pharma is a global manufacturer of injectable pharmaceutical products serving a variety of niche markets, including anesthesiology, orthopedics, rheumatology, urology, and dermatology. An internal development pipeline and an aggressive acquisition strategy for products fuel the company’s growth. RoundTable Healthcare Partners, a private equity firm based in Lake Forest, Illinois, acquired Bioniche Pharma in February 2006. More information about Bioniche Pharma can be found at www.bionichepharma.com.
SOURCE INNOPHARMA LLC