Generex Biotechnology Corporation has been granted price approval by the US Food and Drug Administration approval for the use of Generex Oral-lyn(TM) under the FDA’s Treatment Investigational New Drug (IND) program. Generex was previously granted the FDA approval for the use of Generex Oral-lyn(TM) in patients with Type 1 or Type 2 diabetes mellitus under the FDA’s “Treatment IND” rules.

The U.S. Food and Drug Administration has approved Sanofi-aventis’ Apidra (insulin glulisine injection) to recover glycemic control in children above the age of 4 years suffering from diabetes mellitus. The approval for pediatric use of the injection is based upon FDA’s review of a 6 month long phase III study involving 572 children with type 1 diabetes. Apidra(R), having a rapid onset and shorter period of action, should normally be used along with a basal insulin with a longer duration of action. The product can also be applied in insulin infusion pump treatment for controlling blood sugar.