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Associated Press - September 10, 2009 3:54 PM ET
WORCESTER, Mass. (AP) - Biotechnology company Generex says its flagship diabetes treatment has been approved under a program that allows investigational use of drugs that have not received final approval from the Food and Drug Administration.
Worcester-based Generex says the insulin spray called Oral-lyn will be made available to certain patients with serious or life-threatening Type 1 or Type 2 diabetes, and who are not eligible for enrollment in an ongoing Phase III clinical trial of the drug.
Generex said Thursday that the FDA granted approval for Oral-lyn under the agency's Investigative New Drug program. The program allows access to drugs that are still undergoing clinical testing.
Doctors must be enrolled in the Investigative New Drug program to prescribe the treatment.
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