Generex’ Oral-lyn Receives FDA Price Approval Under Treatment IND Program

Generex Biotechnology (Generex) has received FDA price approval for the use of Oral-lyn under the FDA’s Treatment Investigational New Drug (IND) program.

The company has previously said that the FDA has granted approval for the treatment use of Oral-lyn in patients with type 1 or type 2 diabetes mellitus under its Treatment IND rules. This latest FDA approval will permit the company to charge for the product to recover costs.

However, under the Treatment IND protocol, 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.