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Berlex/Alliance Imavist

Executive Summary

Ultrasound contrast agent Imavist (perfluorohexane) could be approved for evaluation of cardiac function later this year, Alliance says, following submission of additional laboratory testing documentation in response to an Aug. 14, 2000 "approvable" letter from FDA; the agency cited chemistry, manufacturing and controls issues in the letter (1"The Pink Sheet" Aug. 28, 2000, In Brief). Final approval awaits a pre-approval inspection of Alliance's San Diego facility and labeling discussions. Launch is planned for first quarter 2002. Berlex will market the contrast agent
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