Biznes · 31.12.20241 min czytania
Flamingo Pharmaceuticals Ltd.; Withdrawal of Approval of Two Abbreviated New Drug Applications
Automatyczne tłumaczenie lokalne · Oryginalny język źródła
Streszczenie
The Food and Drug Administration (FDA or Agency) is withdrawing approval of two abbreviated new drug applications (ANDAs) from the holder of those ANDAs. The basis for the withdrawal is that the ANDA holder has repeatedly failed to file required annual reports for those ANDAs.