Upsher-Smith’s Androxy (Fluoxymesterone Tablets, USP) CIII Now Available

Upsher-Smith Laboratories (Upsher-Smith) announced has received FDA approval of a supplemental
abbreviated new drug application (sANDA) and request for an alternate active pharmaceutical
ingredient (API) manufacturer for Androxy (Fluoxymesterone Tablets, USP) CIII. The company began shipping ANDROXY™ to its wholesale customers on 9 July 2015.

“When our original API manufacturer discontinued supply, we were required to secure approval from FDA for another API source. As the sole supplier of Fluoxymesterone Tablets in the US, Upsher-Smith made seeking this approval a priority,” said Rusty Field, Chief Commercial Officer, Upsher-Smith. “We are pleased that we can once again make Androxy available to physicians and their patients.”