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Imprese · 18/11/20191 min di lettura
Mayne Pharma Group Limited and Actavis Laboratories UT, Inc.; Withdrawal of Approval of Abbreviated New Drug Applications for Fentanyl Transdermal Systems
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Riepilogo
The Food and Drug Administration (FDA or Agency) is withdrawing the approval of abbreviated new drug application (ANDA) 077062 for the fentanyl transdermal system held by Mayne Pharma Group Ltd. (Mayne) and ANDA 076709 for the fentanyl transdermal system held by Actavis Laboratories UT, Inc. (Actavis), an indirect wholly owned subsidiary of Teva Pharmaceuticals USA, Inc. (Teva). These drug products are both transdermal systems designed with a liquid reservoir. Mayne and Actavis have both requested withdrawal of their respective applications and have waived their opportunity for a hearing.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →