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Geschäft · 15.5.20231 Min. Lesezeit
Final Decision on Withdrawal of MAKENA (Hydroxyprogesterone Caproate) and Eight Abbreviated New Drug Applications Following Public Hearing; Availability of Final Decision
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA or Agency) is announcing the availability of the final decision withdrawing approval of MAKENA (hydroxyprogesterone caproate injection, 250 milligrams (mg) per milliliter (mL), once weekly), under the new drug application (NDA) 021945, held by Covis Pharma Group/Covis Pharma GmbH (Covis), and the eight abbreviated new drug applications (ANDAs) from multiple ANDA holders that reference NDA 021945. The Commissioner of Food and Drugs (the Commissioner) and the Chief Scientist jointly issued the decision following an October 2022 public hearing.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →