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FDA Medical Bulletin * January 1996 * Volume 26
Number 1
Treatment
IND's
The Treatment IND (investigational new drug) protocol is a
mechanism that permits the use of certain investigational
products to treat patients with serious or life-threatening
diseases for which there are no satisfactory alternatives. For
further information on availability of the drugs designated for
Treatment IND status since September 1995, contact the product
sponsors at the telephone numbers listed below.
Cidofovir (Vistide): For HIV-infected persons with
relapsing
cytomegalovirus (CMV) retinitis that has progressed despite
treatment. Gilead Sciences, Inc., 1-800-GILEAD-5.
Autologous peripheral blood lymphocytes activated ex
vivo with
OKT3 monoclonal antibody: For treatment of metastatic (Stage
IV)
renal cell carcinoma. Cellcor, Inc.,
1-800-441-7901.
NPC 702 with carmustine (Gliadel): This is a biodegradable
wafer
impregnated with carmustine that is inserted at the time of
surgical resection of recurrent glioma. Guilford Pharmaceuticals,
Inc., 1-800-701-9035.
REPORT SERIOUS ADVERSE EVENTS AND PRODUCT PROBLEMS TO
MEDWATCH
1-800-FDA-1088
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