Sign the Myodil
Feb 22 1944
15th & Ball Street
Attention 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
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
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 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.
Very Truly Yours,
R. P. Herwick, M.D.
Chief, Drug Division