Florham Park, NJ, April 13th, 2023
Xiromed LLC today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Testosterone Cypionate Injection, USP, generic to Depo-Testosterone®. Xiromed will launch immediately.
Annual market sales for Depo-Testosterone® and its generics for the twelve-month period ending February, 2023 were $193.8 million, according to IQVIA™. Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
Rob Spina, CEO of Xiromed commented, “Testosterone Cypionate Injection is the third product approval from Laboratorios Farmalan, our dedicated injectable hormonal facility in Leon, Spain. This approval bolsters our hormonal products portfolio, and we are pleased to offer another affordable treatment option to U.S. patients.”
Xiromed LLC, located in Florham Park, NJ, is the US generic division of Insud Pharma, S.L., a global pharmaceutical group headquartered in Madrid, Spain. Xiromed is focused on developing and commercializing high quality generic pharmaceutical products for the US market. In addition to its commercial portfolio of generics available in the US, Xiromed has a robust development portfolio of generic pharmaceutical products in various stages of development, including injectable, inhalation and complex generic products. Learn more at http://www.xiromed.com/usa/