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Imprese · 12/09/20141 min di lettura
MK Laboratories, Inc., et al.; Withdrawal of Approval of 3 Abbreviated New Drug Applications for Propoxyphene Products
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Riepilogo
The Food and Drug Administration (FDA) is withdrawing approval of three abbreviated new drug applications (ANDAs) for products containing propoxyphene. The basis for the withdrawals is that the products are no longer shown to be safe because propoxyphene puts patients at risk of potentially serious and even fatal heart rhythm abnormalities. The holders of these ANDAs have waived their opportunity for a hearing.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →