Generex announces USFDA approval of use of company's buccal insulin product
Generex Biotechnology Corporation announced that the U.S. food and Drug Administration (FDA) has granted approval for the treatment use of Generex Oral-lyn™ under the FDA’s Treatment Investigational New Drug (IND) program.
Under a structured Treatment IND protocol, Generex Oral-lyn ™ will be provided to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for the treatment of diabetes, and who are not eligible to participate in the Company’s ongoing global Phase III pivotal clinical trial.
This Treatment IND will be open to eligible patients that comply with the inclusion / exclusion criteria of the protocol, including those who are taking currently approved anti-diabetic medications. There are no oral or injectable medications contraindicated for this IND program.
“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™”, stated Anna Gluskin, Generex’s President and Chief Executive Officer. “This opportunity to provide those in critical need of Generex Oral-lyn™ will continue while the pivotal Phase III 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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