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Zdrowie i gospodarka · 20.04.1999

Certain Single-Entity Coronary Vasodilators Containing Controlled-Release Nitroglycerin; Opportunity for a Hearing

The Food and Drug Administration (FDA) is proposing to withdraw approval of 23 new drug applications (NDA's) and abbreviated new drug applications (ANDA's) for certain single-entity coronary vasodilator drug products containing controlled-release nitroglycerin. 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.

Source: Federal Register — Food and Drug AdministrationOpen original release →