Entreprise · 10/10/20071 min de lecture
Menley & James Laboratories, Inc. et al.; Withdrawal of Approval of Six New Drug Applications
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Résumé
The Food and Drug Administration (FDA) is withdrawing approval of six new drug applications (NDAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of the applications have repeatedly failed to file required annual reports for the applications.