Here's why you can't get Pyridoxamine anymore.

[ Follow Ups ] [ Post Followup ] [ The Islet Foundation Message Forum ] [ FAQ ]

Posted by JoeC on 09:01:16 2006/01/03


Food and Drug Administration

[Docket No. 2005P-0305]

Request for Comment on the Status of Pyridoxamine

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of opportunity to comment.


SUMMARY: The Food and Drug Administration (FDA) is announcing that
comments related to the status of pyridoxamine may be submitted until
December 19, 2005. FDA is requesting comments in response to the
submission of a citizen petition requesting, among other things, that
the agency determine the status of pyridoxamine. All comments
postmarked on or before December 19, 2005 will be accepted as part of
the official record for this matter.

DATES: Submit written comments by December 19, 2005.

ADDRESSES: Submit written comments on the status of pyridoxamine to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to

FOR FURTHER INFORMATION CONTACT: Robert Moore, Center for Food Safety
and Applied Nutrition (HFS-810), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-1441.

SUPPLEMENTARY INFORMATION: On July 29, 2005, FDA received a citizen
petition submitted, under 21 CFR 10.30, by the law firm Morgan Lewis &
Bockius, LLP, on behalf of BioStratum, Inc. The petition requests that
the agency: (1) State in writing that dietary supplements that contain
pyridoxamine are adulterated under the Federal Food, Drug, and Cosmetic
Act; (2) exercise its enforcement authority under the act to remove
from interstate commerce dietary supplements containing pyridoxamine;
and (3) not place this citizen petition in the agency's docket for
premarket notifications for new dietary ingredients (Docket No. 2004N-
In its citizen petition, BioStratum, Inc., states, among other
things, that it is the manufacturer of Pyridorin (pyridoxamine
dihydrochloride), which is the subject of an investigational new drug
application (IND) that was filed with FDA in July 1999 for use as a
potential therapeutic agent to slow or prevent the progression of
diabetic nephropathy in patients with type 1 and type 2 diabetes. The
petition further states that substantial clinical trials have been
conducted for this drug and that the existence of those studies has
been made public. In addition, the petition states that pyridoxamine
was not marketed as a dietary supplement or as a food prior to
Pyridorin's authorization for investigation as a new drug under an IND.
FDA has considered the information and legal argument set forth in
the petition. Based on the facts set forth in the petition, the agency
tentatively concludes that pyridoxamine, the active moiety\1\ of
pyridoxamine dihydrochloride, is excluded from the dietary supplement
definition under the exclusion clause in 21 U.S.C. 321(ff)(3)(B)(ii)
and therefore may not be marketed as or in a dietary supplement.
However, although the petition asserts that there is no evidence that
pyridoxamine was marketed as a dietary ingredient or as a food prior to
the authorization of Pyridorin for investigation under an IND, the
agency is interested in receiving information, if any, that bears on
pyridoxamine's prior marketing as a dietary ingredient or as a food, as
well as other information that would inform the agency's final decision
on the status of pyridoxamine.

\1\ Under 21 CFR 316.3(b)(2), ``active moiety'' means the
molecule or ion, excluding those appended portions of the molecule
that cause the drug to be an ester, salt (including a salt with
hydrogen or coordination bonds), or other noncovalent derivative
(such as a complex, chelate, or clathrate) of the molecule,
responsible for the physiological or pharmacological action of the
drug substance.


[[Page 69977]]

In order to afford all interested parties adequate opportunity to
participate in this matter, the agency requests comments and supporting
information related to this matter. Interested persons may submit to
the Division of Dockets Management (see ADDRESSES) written or
electronic comments regarding this document. Submit a single copy of
electronic comments or two paper copies of any mailed comments, except
that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.

Dated: November 10, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-22884 Filed 11-17-05; 8:45 am]



Follow Ups:

Post a Followup

Optional Link URL:
Link Title:
Optional Image URL:

[ Follow Ups ] [ Post Followup ] [ The Islet Foundation Message Forum ] [ FAQ ]