Dipyridamole; Drugs for Human Use; Drug Efficacy Study Implementation; Withdrawal of Approval of Abbreviated New Drug Applications

Resumen

The Food and Drug Administration (FDA) is withdrawing conditional approval of abbreviated new drug applications (ANDA's) and pertinent parts of ANDA's for certain dipyridamole drug products. FDA is also declaring three unapproved dipyridamole drug products unlawful. FDA is withdrawing approval because there is a lack of substantial evidence that these drugs are effective for long-term therapy of chronic angina pectoris.