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Licensure of Yomesan*

Miles Pharmaceuticals has been licensed by the Food and Drug Administration (FDA) to manufacture and distribute Niclocide (Yomesan)** in the United States for treatment for humans with cestodiasis (tapeworm infections). Drug requests should be directed to local Miles representatives or to: Miles Pharmaceuticals, 400 Morgan Lane, West Haven, CT 06516. Telephone: 800-243-4153 (toll free) or 203-934-9221.

The Parasitic Disease Drug Service (PDDS) of CDC will continue to distribute 13 other drugs to physicians requesting them (Table 5). After the requesting physician provides information about the infection, specific laboratory data, and limited patient data (name, age, sex, and weight), CDC will release these drugs to all licensed physicians in the United States who agree to register as Clinical Investigators by completing FDA Form FD-1573. Included in each shipment is a packet containing 1) a drug protocol outlining indications/contraindications, dosages, routes and frequency of administration, expected adverse reactions, and toxicity; 2) a patient consent form (available in English, Spanish, Cambodian, Lao, Muong (Hmoob), and Vietnamese); and 3) a 1-page patient report form that asks the physician to report all side effects of therapy and record the drug's effectiveness (cure/noncure), as demonstrated by the appropriate laboratory parameters.

Requests for drugs from PDDS should be directed to: Centers for Disease Control, Parasitic Disease Drug Service, 1600 Clifton Road, Bldg. 6, Room 161, Atlanta, GA 30333. Telephone: (Day) 404-329-3670, 8:00 AM to 4:30 PM, Monday through Friday; (night, weekend, or holiday) 404-329-2888, For Emergency Calls Only. Reported by Parasitic Diseases Div, Center for Infectious Diseases, CDC. *Use of trade names is for identification only and does not imply endorsement by the Public Health Service or the U.S. Department of Health and Human Services. **Formerly distributed in the United States by the Parasitic Disease Drug Service (PDDS) as niclosamide (Yomesan).

Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.

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**Questions or messages regarding errors in formatting should be addressed to The U.S. Government's Official Web PortalDepartment of Health and Human Services
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