Upsher-Smith Laboratories announced it has received final approval from the FDA for its New Drug Application (NDA) for Vogelxo (testosterone) gel for topical use.
Vogelxo is a Schedule CIII androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
Endogenous androgens, including testosterone and dihydrotestosterone (DHT) are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of the prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution.
Vogelxo gel will be available in unit-dose tubes and packets in 30-count boxes. Each tube or packet contains 50mg testosterone in 5g of gel. Vogelxo will also be available as a 88g metered-dose pump in 2-count cartons. Each metered-dose pump delivers 12.5mg testosterone per complete actuation (60 pumps).
Vogelxo gel is anticipated to launch in the near future.
For more information call (800) 654-2299 or visit Upsher-Smith.com.