Glass vial 4ml (4cc) , 250 mg of Testosterone undecanoate in 1 ml (1cc)

Nebido injection contains the active ingredient testosterone undecanoate, which is an ester of the naturally occurring male hormone testosterone.

Testosterone is known as an androgen. It is produced by the testicles and is the main hormone essential for normal growth and development of the male sex organs and male sexual characteristics.

The natural production of testosterone is controlled by another set of hormones called gonadotrophins, which are released from the pituitary gland in the brain.

During adult life, testosterone is essential for the production of sperm, the maintenance of sex drive, erectile potency, and the functioning of the prostate gland and other reproductive structures. It also has functions in the skin, muscles, skeleton, kidney, liver, bone marrow and central nervous system.

Low levels of testosterone can cause decreased sex drive, impotence, infertility due to decreased sperm production, decreased mental and physical activity, fatigue and weakening of bones.

Testosterone is given as replacement therapy when natural testosterone levels fall too low, causing symptoms such as those above. Natural testosterone levels fall with age and following surgical removal of the testicles (castration). They may also fall due to decreased functioning of the testicles (hypogonadism or eunuchoidism) caused by testicular disease, or by decreased gonadotrophin production by the pituitary gland, as a result of pituitary disease.

Testosterone replacement allows natural testosterone levels to return to normal, thus relieving the symptoms of the deficiency.

Nebido injection is called a depot injection. It is injected slowly into the muscle of the buttock where it forms a reservoir of medicine. The testosterone is gradually released all the time from the reservoir into the bloodstream. The injection is usually given once every 10 to 14 weeks, though the frequency will depend on your individual testosterone levels. After your first injection you may be asked to come back for another injection after only six weeks, so the correct level of testosterone is reached quickly.

NEBIDO is a novel, long-acting injectable testosterone preparation for the treatment of male hypogonadism. NEBIDO is expected to be the first long-acting testosterone preparation available in the U.S. in the growing market for testosterone replacement therapies. Indevus acquired U.S. rights to NEBIDO from Schering AG, Germany, in July 2005. Approved and launched in Europe, NEBIDO has a substantial data package which the Company has leveraged in its U.S. development activities.

In January 2008, the Company announced additional positive results from its? Phase III program. The Company has been exploring additional dosage regimens to determine if it is possible to achieve a more rapid onset of steady state testosterone pharmacokinetics and still satisfy each of the FDA pre-specified criteria for approvability. This Phase III trial, studied a new treatment regimen in which hypogonadal men were given an initial injection of 750 mg of NEBIDO, followed 4-weeks later by an additional 750 mg loading injection and then 750 mg injections every 10-weeks thereafter.

The data from this Phase III trial demonstrated a highly effective treatment regimen. In the trial, NEBIDO demonstrated a rapid achievement of steady state testosterone levels, minimal excursions outside of the normal range, and an extremely high percentage of patients maintaining a eugonadal (normal) testosterone range. NEBIDO met its primary endpoints, a responder analysis based on average testosterone concentrations during the steady state dosing interval and an outlier analysis based on the maximum testosterone concentrations during the steady state dosing interval. As with the original dosing regimen, treatment with NEBIDO was well tolerated with this new dosing regimen. The data was filed with the FDA as an addition to the NDA originally filed on August 28, 2007.

The Company requested approval of the 750 mg regimen as it believes this regimen distinguishes itself by providing physicians with the optimal long-term dosing solution for treating their male patients with hypogonadism.

On November 1, 2007, the Company announced that the FDA accepted for review the Company's NDA for NEBIDO.

On June 4, 2008, the Company announced that based on a discussion with the FDA regarding the NDA filing for NEBIDO, the Company expects the FDA to formally request that the Company provide additional safety data prior to approving NEBIDO.

On June 30, 2008, the Company announced that it received an approvable letter from the FDA related to the NDA submitted in August 2007. The letter indicated that the application may be approved if the Company is able to adequately respond to certain clinical deficiencies related to the product.

The Company announced on September 26, 2008 that it had met with the FDA and an agreement had been reached with regard to the additional data and risk management strategy that will lead to re-submission (complete response) of the NDA for NEBIDO in the first quarter of calendar 2009. The re-submission database will include experience from over 14,000 injections in more than 2,600 patients, all of which come from existing clinical trials conducted in the US and post-marketing studies that have been conducted in Europe. FDA stated that the number of patients and the number of injections of testosterone undecanoate from these studies appear to provide an adequate size database to determine the precise incidence of serious post-injection, oil-based reactions.

Indevus and FDA also agreed on an education plan to minimize the risks associated with the clinical use of testosterone undecanoate intramuscular injection, namely, to reduce the incidence and/or severity of the serious oil-based reactions. Further, Indevus and FDA agreed to obtain skin-testing data to characterize an allergic component to the drug or any of its excipients in certain patients. Indevus has also agreed to conduct a large, simple post-marketing study of the safety of NEBIDO in approximately 10,000 patients.

Male hypogonadism is an increasingly recognized medical condition characterized by a reduced or absent secretion of testosterone from the testes. Reduced testosterone levels can lead to health problems and significantly impair quality of life. Common effects of hypogonadism include decreased sexual desire, erectile dysfunction, muscle loss and weakness, depression, as well as an increased risk of osteoporosis. Today, there are an estimated four to five million men in the U.S. who suffer from hypogonadism. Of this group, less than ten percent are currently receiving treatment with testosterone replacement therapy. The market is highly-under treated and is expected to grow by more than 10% annually. The U.S. market has experienced rapid growth to approximately $675 million in 2007.

Hypogonadism is primarily diagnosed and treated by specialty physicians, specifically urologists and endocrinologists. Routine testing of testosterone levels has become a more common part of men's health evaluations by specialists. The NEBIDO dosing regimen would fit in well with the physician-recommended follow-up of every three months making it convenient for patients receiving treatment. Current treatment options include gels, patches, and injections, the latter of which requires 13-26 injections per year. The Company believes that the unique profile of NEBIDO will present an opportunity in the growing market for testosterone replacement, and that physicians and patients currently using other methods of treatment may be willing to switch to NEBIDO because of the many benefits of the dosing regimen, including compliance, convenience, and the maintenance of steady serum levels of testosterone.