Xiromed receives FDA nod for generic Delestrogen

Xiromed has received the Food and Drug Administration's nod for estradiol valerate injection, which is the generic of Delestrogen. 

Xiromed’s generic Delestrogen is available in three strengths: 10 mg/ml (5 ml), 20 mg/ml (5 ml) and 40 mg/ml (5 ml). All three strengths are available in a multiple-dose vial. 

[Read more: Xiromed, Genzum unveil generic Naftin]

The medication is used to treat moderate to severe vasomotor symptoms associated with menopause; moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause; hypoestrogenism due to hypogonadism, castration or primary ovarian failure; and advanced androgen-dependent carcinoma of the prostate (for palliation only).

Xiromed will launch immediately.      

Delestrogen and its generics had a market value of $29.8 million for the 12-month period ending March 2023, according to IQVIA.   

[Read more: Xiromed unveils generic Extina]

“Xiromed continues to execute on our strategy to bring hormonal injectable products to market in the United States," said Rob Spina, CEO of Xiromed. "Estradiol valerate injection is Xiromed’s fourth product to launch from Laboratorios Farmalan, our dedicated hormonal injectable facility located in Leon, Spain. I am pleased to add another product to our women’s health generic portfolio, a core therapeutic area in Xiromed’s strategy to bring low-cost pharmaceutical product to U.S. consumers.”