Zdrowie i gospodarka · 25/03/1999
Nitroglycerin Transdermal System; Opportunity for a Hearing
The Food and Drug Administration (FDA) is proposing to withdraw approval of one new drug application (NDA) and five abbreviated new drug applications (ANDA's) for certain single-entity coronary vasodilator drug products containing nitroglycerin in a transdermal system. 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.