Бізнес · 24.04.20261 хв читання
Egis Pharmaceuticals Limited, et al.; Withdrawal of Approval of Three Abbreviated New Drug Applications
Локальний автоматичний переклад · Оригінальна мова джерела
Короткий зміст
The Food and Drug Administration (FDA or Agency) is withdrawing approval of three abbreviated new drug applications (ANDAs) from the holders of those ANDAs. The basis for the withdrawal is that the ANDA holders have repeatedly failed to file required annual reports for those ANDAs.