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Negócios · 12/09/20141 min de leitura
MK Laboratories, Inc., et al.; Withdrawal of Approval of 3 Abbreviated New Drug Applications for Propoxyphene Products
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Resumo
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.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →