Xiromed launches first generic of Balcoltra

Xiromed has received the Food and Drug Administration’s green light for Joyeaux (Levonorgestrel and Ethinyl Estradiol tablets and Ferrous Fumarate tablets), which is the first generic of Balcoltra.

Joyeaux is an oral contraceptive. 

Xiromed said it will launch the product in the United States immediately.   

“I am pleased to announce FDA approval and launch of this first-to-market generic oral contraceptive in the United States. The approval of Joyeaux is an exciting milestone for Xiromed.  As a leading manufacturer of oral contraceptives, we are thrilled to provide an additional choice in generic contraceptive options for patients in the United States," said Rob Spina, CEO of Xiromed.

[Read more: Xiromed intros generic Akovaz]

Spina continued, "Joyeaux is our latest offering, manufactured at our dedicated hormonal facility, Laboratorios Leon Farma SAU, in Spain, and expands upon our extensive portfolio of contraceptive products. This launch demonstrates Xiromed’s ongoing commitment to women’s health care and expanding access to quality, affordable generic drug products for patients in the U.S.” 

Balcoltra had a market value of $47 million annual sales for the 12-month period ending in June 2023. per IQVIA.  

[Read more: Xiromed unveils generic Extina]