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July 8, 1988, Vol 260, No. 2 >
ARTICLE | July 8, 1988

FDA's Newly Designated Treatment INDs FREE

Frank E. Young, MD, PhD; Stuart L. Nightingale, MD
[+] Author Affiliations

Reprint requests to Office of Health Affairs, Room 14-95, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 (Dr Nightingale).


JAMA. 1988;260(2):224-225. doi:10.1001/jama.1988.03410020090034
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References

WE HEREIN describe two new investigational drugs, cytomegalovirus immune globulin and trimetrexate glucuronate, that physicians may obtain under treatment protocols for certain patients with the serious or life-threatening conditions for which the drugs are indicated. The drugs have been approved for early availability under special "Treatment IND" procedures by the commissioner of the Food and Drug Administration.

CYTOMEGALOVIRUS IMMUNE GLOBULIN 

Background  Cytomegalovirus immune globulin (CMVIG), the subject of a Treatment IND, is sponsored by the Massachusetts Public Health Biologic Laboratories, Division of the State Laboratory Institute, Department of Public Health, The Commonwealth of Massachusetts, Boston. The product is indicated for the attenuation of primary cytomegalovirus (CMV) disease associated with kidney transplantation in seronegative recipients of kidneys from seropositive donors. Approximately 75% of untreated seronegative recipients would be expected to develop CMV infection.1 Clinical studies have shown a 50% reduction in primary CMV disease in renal transplant recipients given CMVIG.

REFERENCES

1 +
Snydman DR, McIver J, Leszczynski J, et al:  A pilot trial of a novel cytomegalovirus immune globulin in renal transplant recipients . Transplantation 1984;;38:553-557.
2 +
Snydman DR, Werner BG, Heinze-Lacey B, et al:  Use of cytomegalovirus immune globulin to prevent cytomegalovirus disease in renal-transplant recipients . N Engl J Med 1987;;317:1049-1054.
3 +
Snydman DR, Werner BG, Heinze-Lacey B, et al: Prevention of Kidney Transplant Associated Primary Cytomegalovirus Disease With an Intravenous Cytomegalovirus Immune Globulin (CMVIG-IV): An Interim Analysis , abstracted. Chicago, American Society for Transplant Physicians, 1986;.
4 +
 Update: Acquired immunodeficiency syndrome (AIDS)—United States . MMWR 1986;;35:17-21.
5 +
Haverkos HW:  Assessment of therapy for Pneumocystis carinii pneumonia: PCP Therapy Project Group . Am J Med 1986;;105:37-44.
6 +
Kovacs JA, Heimenz JW, Macher AM, et al:  Pneumoycstis carinii pneumonia: A comparison between patients with the acquired immunodeficiency syndrome and patients with other immunodeficiencies . Ann Intern Med 1984;;100:663-671.

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
Snydman DR, McIver J, Leszczynski J, et al:  A pilot trial of a novel cytomegalovirus immune globulin in renal transplant recipients . Transplantation 1984;;38:553-557.
2 +
Snydman DR, Werner BG, Heinze-Lacey B, et al:  Use of cytomegalovirus immune globulin to prevent cytomegalovirus disease in renal-transplant recipients . N Engl J Med 1987;;317:1049-1054.
3 +
Snydman DR, Werner BG, Heinze-Lacey B, et al: Prevention of Kidney Transplant Associated Primary Cytomegalovirus Disease With an Intravenous Cytomegalovirus Immune Globulin (CMVIG-IV): An Interim Analysis , abstracted. Chicago, American Society for Transplant Physicians, 1986;.
4 +
 Update: Acquired immunodeficiency syndrome (AIDS)—United States . MMWR 1986;;35:17-21.
5 +
Haverkos HW:  Assessment of therapy for Pneumocystis carinii pneumonia: PCP Therapy Project Group . Am J Med 1986;;105:37-44.
6 +
Kovacs JA, Heimenz JW, Macher AM, et al:  Pneumoycstis carinii pneumonia: A comparison between patients with the acquired immunodeficiency syndrome and patients with other immunodeficiencies . Ann Intern Med 1984;;100:663-671.

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