Generex wins FDA price approval for new diabetes drug in treatment IND program

Thu. October 15, 2009; Posted: 08:52 AM

Oct 15, 2009 (Datamonitor via COMTEX) -- GNBT | Quote | Chart | News | PowerRating -- Generex Biotechnology, a developer of drug delivery systems and technologies, has reported that the FDA has granted price approval in respect of the use of Generex Oral-lyn under the FDA's treatment investigational new drug or IND program.

Under the treatment IND protocol, Generex Oral-lyn will be provided to patients with life-threatening or otherwise serious type 1 or type 2 diabetes mellitus where there is no satisfactory alternative therapy available to treat the condition.

This new FDA approval will permit the company to charge for the product to recover costs. This treatment IND is open to persons meeting the protocol's inclusion criteria, including those who are taking currently approved anti-diabetic medications.

Generex will be providing information in respect of the availability of Generex Oral-lyn under the treatment IND. Details will include the protocol's inclusion and exclusion criteria, study design and participating sites and/or physicians. The drug will be available only through physicians who are registered in the treatment IND program.

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For full details on Generex Biotechnology (GNBT) click here. Generex Biotechnology (GNBT) has Short Term PowerRatings of 8. Details on Generex Biotechnology (GNBT) Short Term PowerRatings is available at This Link.

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