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                  <text>~

July 19,'1968
Dr. Merle L. Gibson
Acting Director
Division of Neuropharmacological Drugs

Office of New Drugs
Bureau of Medicine
Food and Drug Administration

washington, D.C. 20204
Dear Merle,

I want to thank you for the cooperation which you have
expressed on behalf of the FDA to Endo Laboratories regarding
naloxone. In a meeting with one of their vice presidents
last week, we were assured that supplies of naloxone would be
made available for clinical trial early in August.
I

writing to ask your advice on another matter. In
investigated the effects of intravenous procyclidine
in patients receiving convulsﬁye therapy.' Recently
in response
to suggestions from NINE, I have reestablished a study program
am

1956~58 I

in convulsive therapy. It seems advisable to repeat some of
the observations made earlier and to build on that
With this in mind, I called Burroughs Wellcome and experience.
requested
a supply of parenteral procyclidine, since such is not listed
in the PDR. Dr. William Calvin indicated that the IND for
parenteral procyclidine was withdrawn and supplies of parenteral
procyclidine were no longer available but could be produced.
When I asked that he do
so, at our expense, he indicated that
this was not possible insofar as the IND had been withdrawn.
are the steps necessary for me to meet existing FDA
and to permit Burroughs Wellcome to supply parenteral
procyclidine for experimental use in a project approved by the
appropriate authorities of the college, NIMH and the City of
What

regulations

New

York.

Thank you

for your assistance.
Sincerely yours,
Fink, M.D.
Professor of Psychiatry

Max

MP:kp

.

»,~—.-7,.,,,,

va—

�</text>
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              <text>1968 </text>
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              <text>Special Collections and University Archives, University Libraries. Stony Brook University Libraries (State University of New York).</text>
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