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FDA grants limited approval to investigational diabetes drug


WORCESTER, Mass. The Food and Drug Administration has allowed the use of an investigational treatment in patients with diabetes.

Generex Biotechnology Corp. announced Thursday that the FDA had granted approval for the treatment use of the orally administered insulin Oral-lyn for patients with serious or life-threatening Type 1 or Type 2 diabetes under the agency’s Treatment Investigational New Drug program. The drug is undergoing global phase 3 trials.

The program allows drug makers to provide early access to investigational drugs for patients with conditions for which there is no satisfactory alternative treatment. Such drugs must demonstrate the prospect of efficacy through clinical testing.

“We are excited about having the opportunity to meet the needs of American patients living with diabetes who have no satisfactory alternative treatment and have contacted the company, based on their special needs, about possible access to Generex Oral-lyn,” Generex president and CEO Anna Gluskin said in a statement. “This opportunity to provide those in critical need of Generex Oral-lyn will continue while the pivotal phase 3 study concludes, and the company prepares for its new drug submission with the USFDA and other major health authorities in key markets.”

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