CyclospasmolRegister; Final Decision on Proposed Withdrawal of Approval of New Drug Application

Samenvatting

The Food and Drug Administration (FDA) is announcing that the Commissioner of Food and Drugs (the Commissioner) is issuing his Final Decision on the proposal to withdraw approval of the new drug application (NDA) for the human drug product Cyclospasmol (cyclandelate) (NDA 11-544). This drug is labeled for use in two indications: specifically, as a treatment for intermittent claudication caused by arteriosclerosis obliterans and as a treatment for cognitive dysfunction in patients suffering from senile dementia of the multiinfarct or Alzheimer's type. The Commissioner has determined that Cyclospasmol has not been shown to be effective for such uses, and the Commissioner hereby withdraws approval for this drug. The Commissioner's Decision sustains the Initial Decision of the Administrative Law Judge (ALJ), who found that Cyclospasmol had not been shown by sufficient evidence of adequate and well- controlled studies to be effective for its intended uses.