FDA expands Myoview label
Amersham Health has won FDA approval to market its Myoview radiopharmaceutical for the assessment of left ventricular function, specifically the calculation of LV ejection fraction and wall motion, in patients being evaluated for heart disease. The
Amersham Health has won FDA approval to market its Myoview radiopharmaceutical for the assessment of left ventricular function, specifically the calculation of LV ejection fraction and wall motion, in patients being evaluated for heart disease. The company's second largest selling product was first FDA approved and introduced in the U.S. in 1996 for cardiac perfusion studies. The additional indication is the latest example of Amersham's corporate strategy to expand the clinical utility of current products (SCAN 4/17/02).
In 2001, the FDA expanded Myoview labeling to include its use with pharmacologic stress agents in patients with known or suspected coronary artery disease. Last year, European authorities approved its use for imaging breast cancer. The product currently accounts for about 40% of the technetium cardiac market and more than 30% of the global myocardial perfusion market, according to Amersham.
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