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June 4, 1997

Availability of Diphtheria Antitoxin Through an Investigational New Drug Protocol

JAMA. 1997;277(21):1665. doi:10.1001/jama.1997.03540450021010

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ALTHOUGH diphtheria is a rare disease in the United States, access to diphtheria antitoxin (DAT) is essential to ensure effective treatment of a case. The previously available supply of U.S.-licensed DAT (Diphtheria Antitoxin, Equine, Connaught Laboratories, Inc., Swiftwater, Pennsylvania) had an expiration date of January 6,1997, and should no longer be used. No manufacturer has announced an intention to license a DAT product in the United States.

A DAT product (i.e., Diphtheria Antitoxin, Pasteur Merieux, Lyon, France), licensed in Europe and similar to the previously licensed U.S. product, is now available in the United States through an Investigational New Drug (IND) protocol through CDC. This protocol is designed to enable the emergency treatment of patients with suspected diphtheria. Decisions to dispense DAT from U.S. Public Health Service quarantine stations will be made by medical epidemiology staff of CDC's Child Vaccine Preventable Disease Branch, Epidemiology and Surveillance Division, National