Yuvafem Treatment for Menopausal Symptoms Set to Launch

Amneal Pharmaceuticals will begin shipping Yuvafem, the first generic equivalent of Novo Nordisk’s Vagifem, this October.

Yuvafem is a vaginal tablet of estradiol 10 mcg delivered through a preloaded, single-use, disposable applicator. The product is packaged in 8- and 18-count sizes for initial and maintenance treatment.

Yuvafem is indicated to treat menopausal symptoms such as vaginal dryness, irritation, itching, and soreness, as well as painful urination and pain and bleeding during sex. One tablet should be administered daily for 2 weeks, followed by one tablet twice weekly.

“With Yuvafem, patients and health care providers who prefer this unique dosage form now have another, more affordable option for treatment,” said Chirag Patel, Amneal co-CEO and chairman, in a press release.

The most common adverse reactions associated with Yuvafem in randomized, placebo-controlled, double-blind studies were upper respiratory tract infection, headache, abdominal pain, back pain, genital pruritus, moniliasis, vulvovaginal mycotic infection, and diarrhea.

Yuvafem should not be used by women who have abnormal genital bleeding or known liver impairment or disease. It should also be avoided by patients who have a known, suspected, or past history of breast cancer.