FDA approves CIS-US generic version of radioisotope preparation kit

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CIS-US has received approval from the FDA Office of Generic Drugs to manufacture and market a generic Choletec Kit for the preparation of Technetium Tc-99m Mebrofenin.

The company will begin distribution the week of February 4.

The kit is the second agent in the CIS-US product line approved with an indication for hepatobiliary imaging, said the Bedford, Mass.-based company.

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