Determination That the OXYCONTIN (oxycodone hydrochloride) Drug Products Covered by New Drug Application 20-553 Were Withdrawn From Sale for Reasons of Safety or Effectiveness

Document ID: FDA-2011-P-0473-0011
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2013-09092
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Details Information

Document Subtype: General Notice
Received Date: April 18 2013, at 12:00 AM Eastern Daylight Time
Start-End Page: 23273 - 23275
Page Count: 3
Comment Start Date: April 18 2013, at 12:00 AM Eastern Standard Time

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List of References

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Reference 1 Policy Impact Prescription Painkiller Overdoses

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Reference 10 Integrated Prevention Services for HIV Infection Viral Hepatitis Sexually Transmitted Diseases and Tuberculosis for Persons Who Use Drugs Illicitly Summary Guidance From the CDC and the US Department of Health and Human Services

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Reference 11 Intranasal Hydrocodone Acetaminophen Abuse Induced Necrosis of the Nasal Cavity and Pharynx

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Reference 2 Vital Signs Overdoses of Prescription Opioid Pain Relievers United States 1999 2008

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Reference 3 Unintentional Drug Poisoning in the United States

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Reference 4 Pharmaceutical Overdose Deaths, United States, 2010

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Reference 5 FDA Blueprint for Prescriber Education for Extended Release and Long Acting Opioid Analgesics

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Reference 6 Draft Guidance for Industry Abuse-Deterrent Opioids Evaluation and Labeling

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Reference 7 Tampering With Prescription Opioids Nature and Extent of the Problem Health Consequences and Solutions

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Reference 8 Factors Associated With History of Non Fatal Overdose Among Young Nonmedical Users of Prescription Drugs

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Reference 9 Mortality Among Regular or Dependent Users of Heroin and Other Opioids A Systematic Review and Meta Analysis of Cohort Studies

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