İş dünyası · 10.07.20191 dk okuma
Apotex, Inc.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
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Özet
The Food and Drug Administration (FDA or Agency) is withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex, Inc. (Apotex). Apotex, through its U.S. agent, has requested withdrawal of these applications and has waived its opportunity for a hearing.