September 10, 2009
Worcester Drug Firm Gets FDA Go-Ahead
By Matthew L. Brown
Worcester-based Generex Biotechnology Corp. said it has received U.S. Food and Drug Administration approval for its diabetes drug.
The FDA granted Generex's Oral-lyn approval as an investigational new drug, which allows companies to provide those drugs to patients with serious or life-threatening conditions for which there is no alternative treatment.
Drugs that are approved as investigational must demonstrate "the prospect of efficacy" through clinical testing.
Generex is developing drugs that can be delivered through the inner lining of the mouth. Similar drugs would typically be administered by injection. The drugs are delivered by the company's RapidMist device.
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