Zdrowie i gospodarka · 07/07/2000

Certain Single-Entity Coronary Vasodilators Containing Isosorbide Dinitrate; Withdrawal of Approval of Abbreviated New Drug Applications

The Food and Drug Administration (FDA) is withdrawing conditional approval of 25 abbreviated new drug applications (ANDA's) for certain single-entity coronary vasodilator drug products containing isosorbide dinitrate. FDA is withdrawing approval because there is a lack of substantial evidence that these drugs are effective for their labeled indications relating to the treatment and prevention of anginal attacks. The sponsors of these conditionally approved products failed to provide required adequate bioavailability/bioequivalence data on the products to support full approval of the applications.