The Food and Drug Administration has withdrawn conditional approval for certain drug products containing dipyridamole because there is a lack of sufficient evidence that these drugs are effective for long-term therapy of chronic angina pectoris.
Approval had been granted on condition that additional evidence of effectiveness for this indication was provided. Since this information has not been provided the agency has withdrawn approval for this indication. Approval has been granted for products containing dipyridamole for the indication “as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacements”.
Reference: Federal Register 64 (3): 884-886 (1999).