Upsher-Smith announced that the Food and Drug Administration (FDA) has approved the supplemental abbreviated new drug application (sNDA) and request for an alternate active pharmaceutical ingredient (API) manufacturer for Androxy (fluoxymesterone) tablets.
The original API discontinued the supply and Upsher-Smith was required to obtain FDA approval for another API source.
Androxy, a CIII controlled substance, is a synthetic androgen indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone in congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism. It is also indicated to stimulate puberty in selected males with delayed puberty. Endogenous androgens are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Also, they are responsible for the growth spurt of adolescence and for the eventual termination of linear growth which is brought about by fusion of the epiphyseal growth centers.
Androxy is available as 10mg tablets in 100-count bottles. Upsher-Smith has begun shipping the product.
For more information call (800) 654-2299 or visit Upsher-Smith.com.