Comment from Kenvue Brands LLC part 4 of 4
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Summary: The submission consists of meeting minutes from two different FDA advisory committees (the Joint Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in 2015, and the Pediatric Advisory Committee in 2017) regarding the safety and use of codeine and hydrocodone in children. It does not express a specific stance on the "Americans for Scientific Integrity" citizen petition but rather provides historical regulatory context and committee findings.
Submission 4 of 4 in support of Kenvue Brands LLC’s response to the Citizen Petition
Attachments
- Footnote 45 - Summary Minutes of the Joint Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Meeting (PDF)
- Footnote 46 - Minutes of the Pediatric Advisory Committee (Sept 11 2017)_FDA (PDF)
- Footnote 48 - CDC_National Surveillance for Reye Syndrome 1981_Update - Reye Syndrome and Salicylate Usage (PDF)
- Footnote 49 - CDC_Surgeon General's Advisory on the Use of Salicylates and Reye Syndrome (PDF)
- Footnote 53 - Aspirin Labels to Warn About Reye Syndrome - The New York Times
- Footnote 57 - Acetaminophen is Safe for Children When Taken as Directed_American Academy of Pediatrics
- Footnote 58 - NAPNAP Official Statement on Acetaminophen Use_National Association of Pediatric Nurse Practioners (PDF)
- Footnote 59 - Safety of Tylenol (Acetaminophen) for Children and in Pregnancy_ Frequently Asked Questions_Children's Hospital of Philadelphia (PDF)
- Footnote 60 - Nationwide Hospital Guidance (PDF)
- Footnote 61 - Statement to Congress_ Acetaminophen (Tylenol) and Autism_National Hispanic Health Foundation (PDF)
- Footnote 62 - Acetaminophen and autism_what is safe for children_Society for Pediatric Pain Medicine (PDF)
- Footnote 74 - Over-the-Counter (OTC) Drug Review_OTC Monograph Reform in the CARES Act_FDA (PDF)
- Footnote 76a - Acetaminophen injection for intravenous use _Drugs at FDA (Feb 18 2021) (PDF)
- Footnote 76b - Acetaminophen injection for intravenous use _Drugs at FDA (June 2021) (PDF)
- Footnote 78a - Brit and Gottlieb (2021)
- Footnote 78b - Acetaminophen Dosing Tables for Fever and Pain in Children_HealthyChildren.org (PDF)
- Footnote 78c - Ibuprofen Dosing Table for Fever and Pain_HealthyChildren.org (PDF)
- Footnote 80 - CDC_How to Treat Chickenpox (PDF)
- Footnote 81 - Mayo Clinic_Influenza (flu) Diagnosis and treatment