The testosterone replacement products currently approved by the FDA are two intramuscular testosterone products (injected every 2-4 weeks), transdermal patches, gel, a solution, a buccal bioadhesive system, an oral tablet, and a subcutaneous implant.
Speaking on behalf of the Endocrine Society during the open public hearing portion of the meeting, Dr. Allan Glass, an endocrinologist in Bethesda, Md., said that the Society’s current guidelines for the treatment of androgen deficiency say that TU is an acceptable treatment in countries in which it has been approved (J. Clin. Endocrinol. Metab. 2010;95:2536-59).
If approved in the United States, TU will be marketed as Aveed. It is marketed in about 72 countries, and in Europe it is marketed as Nebido. The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Dr. Glass had no financial disclosures.