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Zdrowie i gospodarka · 6.07.2012

Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and Labeled for Human Use; Enforcement Action Dates

The Food and Drug Administration (FDA or Agency) is announcing its intention to take enforcement action against all unapproved single- ingredient, immediate-release drug products that contain oxycodone hydrochloride (hereinafter "oxycodone") for oral administration and are labeled for human use, and persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. Unapproved oxycodone drug products have been implicated in reports of medication errors causing serious adverse events. In addition, some of these products omit important warning information in their labeling. Single-ingredient, immediate-release oxycodone drug products are new drugs that require approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs) to be legally marketed.

Source: Federal Register — Food and Drug AdministrationOpen original release →