First Generic Transdermal Testosterone Gel Launched in U.S.
Product is generic version of Vogelxo
Testosterone Gel 1% — the first generic testosterone replacement therapy — has been launched in the U.S. The product is the generic form of the recently approved Vogelxo (testosterone) gel 1% for topical use. Both medications are manufactured by Upsher-Smith Laboratories.
Vogelxo and Testosterone Gel 1% are prescription medications that contain testosterone. Both are used to treat adult males with low or no testosterone and with conditions associated with low or no testosterone. Testosterone Gel 1% is applied once daily and provides 24-hour coverage.
It is not known whether Vogelxo and Testosterone Gel 1% are safe or effective in children younger than 18 years of age. Improper use of these products may affect bone growth.
According to the American Urological Association, 39% of men over the age of 45 have low testosterone, but few are being treated. Methods of treatment include injections, patches, and topical gels.
Testosterone Gel 1% is supplied in three forms: unit-dose tubes, unit-dose packets, and metered-dose pumps. Each tube or packet contains 50 mg of testosterone in 5 g of gel. Each metered-dose pump delivers 12.5 mg of testosterone per complete pump actuation.
Vogelxo and Testosterone Gel 1% are controlled substances (CIII) because they contain testosterone, which can be a target for people who abuse prescription medications.
The most common side effects of Vogelxo and Testosterone Gel 1% include skin irritation where the products are applied; increased red blood cell count; headache; and increased blood pressure.
Male hypogonadism is a condition in which the body does not produce enough testosterone — the hormone that plays a key role in masculine growth and development during puberty. Signs and symptoms associated with low levels of testosterone include erectile dysfunction, decreased sexual desire, fatigue and loss of energy, depression, regression of secondary sexual characteristics, and osteoporosis.
Source: Upsher-Smith; July 2, 2014.