FDA approves CIS-US generic version of radioisotope preparation kit
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.
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.