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Expanded use of MYOVIEW close to approval:

This article was originally published in Clinica

Executive Summary

Nycomed Amersham Imaging has received an approvable letter from the US FDA for the additional use of its MYOVIEW radiopharmaceutical with pharmacologic stress agents, which are specifically used in the diagnosis of coronary artery diseases in patients unable to exercise physically. The letter comes 10 months after the initial submission. MYOVIEW was launched in the US in 1996 and has a 30% share of the US technetium cardiac market, says the product's Princeton, New Jersey-based developer.

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