the Myodil Action Group e-petition
15th & Ball Street
of Mr. W. B. Bucke,
We have your letter of February 15 with which you have submitted additional
material for your pending application under section 505 of the Federal Food,
Drug and Cosmetic Act for the preparation “Pantopaque.”
We have completed our study of this application and it has been concluded
that no order will issue under section 505(d) of the Act to refuse to permit
the application to become effective.
This application is effective with respect to the use of this drug only
under the conditions prescribed, recommended and suggested in the
application. Should you decide to alter the composition, or dosage, or
method or duration of administration or application, or other condition of
use, an appropriate amendment to the application should be submitted for
Your attention is directed to section 301(1), which prohibits the use in the
labelling or in any advertising of any statement to the effect that an
application with respect to this drug is effective under section 505 or that
the drug complies with the provision of that section.
Section 505(e) of the Act provides for the suspension of the effectiveness
of an application if further experience and tests with the article show it
to be unsafe for use or if it is found that the application contains any
untrue statement of a material fact.
The effectiveness of this application under section 505 in no way relieves
you of the necessity of complying with the requirements of all other
provisions of the Act applicable to the preparation.
We have no comment to offer on either the labels or proposed circular. As
soon as available you should submit five copies of the printed labels
together with five copied of the printed circulars.
P. Herwick, M.D.
WVW:mbc 2/21/44 Chief,