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Takeda Pharmaceuticals U.S.A., Inc.; Withdrawal of Approval of New Drug Application for EXKIVITY (Mobocertinib Succinate) Capsule, Equivalent to 40 Milligrams Base
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Zusammenfassung
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for EXKIVITY (mobocertinib succinate) capsule, equivalent to (EQ) 40 milligrams (mg) base, held by Takeda Pharmaceuticals U.S.A., Inc., 95 Hayden Ave., Lexington, MA 02421 (Takeda). Takeda has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →