Zdrowie i gospodarka · 22.03.1999
Certain Single-Entity Coronary Vasodilators Containing Isosorbide Dinitrate; Opportunity for a Hearing
The Food and Drug Administration (FDA) is proposing to withdraw approval of 25 abbreviated new drug applications (ANDA's) for certain single-entity coronary vasodilator drug products containing isosorbide dinitrate. FDA is offering the holders of the applications an opportunity for a hearing on the proposal. The basis for the proposal is that the sponsors of these products have failed to submit acceptable data on bioavailability and bioequivalence.