Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Pyridoxamine

This article was originally published in The Tan Sheet

Executive Summary

The Council for Responsible Nutrition requests a 90-day extension period to comment on the status of pyridoxamine as a dietary supplement. "There is very strong evidence" that the ingredient was marketed prior to the enactment of DSHEA, CRN maintains in a Dec. 16 letter to FDA. However, the group began contacting members in November for evidence of sale and "the search for documentary evidence is proving difficult and tedious." CRN has identified two firms "whose former employees believe they marketed pyridoxamine during that era" and who are continuing their search for evidence. FDA sought comment in a Nov. 18 Federal Register that "tentatively" concluded the ingredient was not a supplement ("The Tan Sheet" Nov. 21, 2005, p. 13). Debate began when a July citizen petition by BioStratum requested that sales of supplements containing pyridoxamine cease. The firm filed an investigational new drug application in 1999 for Pyridorin, which contains the ingredient...

You may also be interested in...



Pyridoxamine Debate Prompts FDA Comment Period

FDA tentatively has concluded that pyridoxamine is not a dietary supplement and has opened a 30-day comment period inviting information on the ingredient's prior marketing as a dietary ingredient or food

US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing

The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.

COVID-19: US Acted To Beat Other Countries To Next 1.25M Doses Of Regeneron Cocktail

Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.

Topics

UsernamePublicRestriction

Register

PS051363

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel