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UNITED STATES v. ARTICLES OF DRUG

No. 83 C 6129.

624 F.Supp. 776 (1985)

UNITED STATES of America, Plaintiff, v. ARTICLES OF DRUG ... Promise Toothpaste for Sensitive Teeth ... Active Ingredients: Potassium Nitrate, Sodium Monofluorophosphate ... Sensodyne-F Toothpaste for Sensitive Teeth ... Active Ingredients: Potassium Nitrate, Sodium Monofluorophosphate ... and Block Drug Company, Inc., and Leonard N. Block and James A. Block, Defendants.

United States District Court, N.D. Illinois, E.D.

As Amended December 5, 1985.

Attorney(s) appearing for the Case

Michael S. O'Connel, Asst. U.S. Atty., Chicago, Ill., Ann H. Wion, FDA Associate Chief Counsel for Enforcement, Rockville, Md., for plaintiff.

Joan M. Hall, Daniel J. King, Jenner & Block, Chicago, Ill., Alan H. Kaplan, Thomas O. Henteleff, David E. Kaplan, Kleinfeld, Kaplan & Becker, Washington, D.C., for defendants.

MEMORANDUM OPINION AND ORDER

GETZENDANNER, District Judge:

In this drug enforcement action, the United States seeks seizure and condemnation of certain over-the-counter ("OTC") drug products, Promise toothpaste with Fluoride and Sensodyne-F toothpaste. The government alleges that these products are "new drugs" within the meaning of 21 U.S.C. § 321(p)(1), and were introduced into interstate commerce without an approved New Drug Application ("NDA"), as...

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