Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced that the US Food and Drug Administration (FDA) has granted price approval in respect of the use of Generex Oral-lyn under the FDA's Treatment Investigational New Drug (IND) programme.
Generex previously announced that the FDA has granted approval for the treatment use of Generex Oral-lyn in patients with type-1 or type-2 diabetes mellitus under the FDA's 'Treatment IND' rules.
This latest FDA approval will permit the company to charge for the product to recover costs.
The FDA's Treatment IND regulation was established in 1987 to make promising new drugs available to patients with life-threatening or otherwise serious medical conditions as early in the drug development process as possible. Preliminary evidence of drug efficacy is a condition precedent to the approval of a Treatment IND. Treatment INDs are made available to patients before general marketing begins, typically during phase-3 studies.
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 Treatment IND is open to persons meeting the protocol's inclusion criteria, including those who are taking currently approved anti-diabetic medications.