Androxy Available Again for Testosterone Replacement

The FDA approved the company's sNDA in July of last year
The FDA approved the company's sNDA in July of last year

Upsher-Smith announced that Androxy (fluoxymesterone) tablets are now available. 

After the original manufacturer of the active pharmaceutical ingredient (API) discontinued the supply, the Food and Drug Administration (FDA) approved the Company's supplemental New Drug Application (sNDA) and request for an alternative manufacturer for Androxy in July 2015.

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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 strength tablets in 100-count bottles.

For more information call (800) 654-2299 or visit Upsher-Smith.com.

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