Upsher-Smith’s Androxy available after API manufacturer switch

MAPLE GROVE, Minn. — Upsher-Smith Labarotories announced Monday that it had its Androxy (fluoxymesterone) tablets are available following the Food and Drug Administration’s approval of the company’s request for a new active pharmaceutical ingredient manufacturer and supplemental abbreviated new drug application. 

 

Androxy tablets are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. As the sole U.S. supplier of fluoxymesterone, Upsher-Smith sought a way to renew the product’s availability after the company’s initial API manufacturer discontinued its supply. 

 

"We are pleased that we can once again make ANDROXY™ available to physicians and their patients,” Upsher-Smith’s Chief Commercial Officer Rusty Field said.