Generex says ruling will allow it to provide Generex Oral-lyn to some patients before approval
By APThursday, September 10, 2009
FDA allows emergency use of Generex diabetes drug
WORCESTER, Mass. — Generex Biotechnology Corp. said Thursday the Food and Drug Administration approved experimental use of its diabetes drug candidate Generex Oral-lyn.
The FDA approved what is called a treatment investigational new drug program, which allows drug makers to make unapproved drug available to patients with dangerous illnesses who don’t have a satisfactory treatment.
Generex Oral-lyn will be provided to patients with life-threatening type 1 or type 2 diabetes who are not eligible for a current late-stage trial.
The company makes drugs that are taken through the inner lining of the mouth, for use against metabolic diseases.
During the regular trading day, Generex stock surged 15 cents, or 22.6 percent, to close at 83 cents. The shares slipped to 81 cents in trading after hours.
