CIS-US Announces Approval Of Generic Version Of Choletec(R) Kit For The Preparation Of Technetium Tc-99m Mebrofenin

Main Category: Radiology / Nuclear Medicine
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices
Article Date: 01 Feb 2008 - 3:00 PDT

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CIS-US, Inc. announced that it has received approval from the U. S. Food and Drug Administration (FDA) Office of Generic Drugs for its Abbreviated New Drug Application (ANDA) to manufacture and market a generic Kit for the Preparation of Technetium Tc-99m Mebrofenin. The company will begin distribution the week of February 4.

The Kit for the Preparation of Technetium Tc-99 Mebrofenin is the second agent in the CIS-US product line approved with an indication for hepatobiliary imaging.

Jeanne A. Fiore, VP Regulatory Affair and Quality Assurance, stated, "We are pleased to receive approval of our first ANDA filing and the first generic approval for a Kit for the Preparation of Technetium Tc-99 Mebrofenin."

Glenn Alto, President and CEO of CIS-US stated, "Our approval of the Kit for the Preparation of Technetium Tc-99 Mebrofenin is a gratifying start to the expansion of our existing molecular imaging agent product line. Our commitment to the development, production and supply of key products to nuclear medicine practitioners and their patients will be evidenced as we continue to grow our product offerings in the coming months."

About CIS-US, Inc.

CIS-US, Inc. is a specialty pharmaceutical company headquartered in Bedford, MA with a focus in the manufacture and marketing of molecular imaging agents and in providing contract manufacturing and development services for human parenteral compounds.

This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to plans and projections. These statements may be identified by the fact that they use words such as "anticipate," "estimate," "believe" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

CIS-US, Inc.