FDA OKs expanded use for Kinevac

Bracco Diagnostics has received approval from the Food and Drug Administration to implement a labeling change to Kinevac (sincalide for injection) for all imaging modalities. Kinevac was originally approved for use with cholecytography or ultrasonography. The labeling change means that the agent will now cover other hepatobiliary imaging techniques including cholescintigraphy.

The Princeton, NJ-based company has also received patent approval for a new formulation of Kinevac. This approval extends patent protection on the contrast agent until 2022, Bracco said.

By AuntMinnie.com staff writers
June 1, 2005

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