FDA approves sANDA and Request for Alternate Active Pharmaceutical Ingredient Manufacturer

Maple Grove, MN – July 27, 2015 – Upsher-Smith Laboratories, Inc. (Upsher-Smith) announced that it has received U.S. Food and Drug Administration (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 July 9, 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 U.S., 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."

Product Information
The NDC number for ANDROXY™ (Fluoxymesterone Tablets, USP) CIII in 100-count bottles is 0832-0086-00. For questions about ordering ANDROXY™, please call Upsher-Smith at 1-800-654-2299.

About Upsher-Smith 
Upsher-Smith Laboratories, Inc., founded in 1919, is a growing, fully integrated pharmaceutical company dedicated to its mission of delivering high-value, high-quality therapies and solutions which measurably improve individuals' lives. As a family-owned pharmaceutical company, we are able to adapt and thrive in a dynamic healthcare environment. Our world is constantly evolving, and we are continually adapting to the ever-changing needs of patients, physicians, pharmacists, and healthcare organizations. Where there is a need, we will work to deliver solutions that simplify access to treatment, deliver better health outcomes, and enhance life. Upsher-Smith has a particular focus on developing therapies for people living with central nervous system (CNS) conditions, such as seizure disorders. For more information, visit

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