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Geschäft · 17.2.20231 Min. Lesezeit
Miles Laboratories Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for Alcohol and Dextrose Injection; 5 Milliliters/100 Milliliters, 5 Grams/100 Milliliters
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Zusammenfassung
The Food and Drug Administration (FDA or Agency) is withdrawing approval of an abbreviated new drug application (ANDA) for Alcohol and Dextrose Injection, 5 milliliters (mL)/100 mL, 5 grams (g)/ 100 mL. The bases for the withdrawal are that the ANDA holder has repeatedly failed to file required annual reports for this ANDA and that the Agency has scientific data and experience to show that the drug product under this ANDA is unsafe for use under the conditions of use for which the product was approved.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →