Gensia's GenESA Not Approvable, Says FDA
The US Food and Drug Administration has decided that Gensia's GenESA (arbutamine) cardiac stress testing sytem is not approvable, according to the company.
Phase III trials of GenESA suggested that GenESA was equivalent to exercise testing in the diagnosis of coronary artery disease, although side effects were significantly higher. Gensia filed a New Drug Application for the product in December 1993, reports the Pink Sheet. The company did not specify about what the FDA was concerned, but said that it would be meeting with the agency "as soon as possible" to determine an appropriate course of action.
GenESA comprises a drug and computer controlled drug administration system which is intended for use in patients unable to exercise adequately for stress tests.
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