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Generex Biotechnology Corporation (Nasdaq:GNBT), Worcester, Mass., a leader in drug delivery for metabolic diseases through the inner lining of the mouth, has expanded its plans for its United States Food and Drug Administration (FDA) Expanded Access Treatment IND Program for its flagship product, Generex Oral-lyn(TM), to include licensed and qualified Nurse Practitioners in the United States.
Nurse Practitioners in a total of 11 states within the United States have the authority to issue prescriptions to patients without medical doctor collaboration.
In September, 2009, the FDA approved the treatment use of Generex Oral-lyn(TM) under the FDA's Treatment Investigational New Drug (IND).
The FDA's Treatment IND program allows companies to provide early access to investigational drugs for patients with serious or life-threatening conditions for which there is no satisfactory alternative treatment. Drugs that are granted approval by the FDA for the Treatment IND program MUST demonstrate the prospect of efficacy...