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Lafayette Pharmacal, Inc,                            Feb 22 1944
15th & Ball Street
Lafayette, Indiana

Gentlemen:                                                 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 “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 consideration.

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.

Cc CD C                         Very Truly Yours,
Cc Drug Div                    R. P. Herwick, M.D.
WVW:mbc 2/21/44          Chief, Drug Division