Jan 30, 2008 - CIS-US, Inc. announced today 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."
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