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Geschäft · 25.9.20011 Min. Lesezeit
Solvay Pharmaceuticals, Inc.; Withdrawal of Approval of Two New Drug Applications
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA) is withdrawing approval of two new drug applications (NDAs) held by Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA 30062. In 1997, the agency informed Solvay of its intention to assess the validity of data and information in all of Solvay's pending and approved applications. However, Solvay does not intend to conduct validity assessments of the two NDAs named in this notice because the products are no longer marketed. Solvay has agreed to permit FDA to withdraw approval of the applications, thereby waiving its opportunity for a hearing.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →