Generic Version of Vagifem Launched

Amneal has launched the first-to-market generic version of Vagifem, being sold as Yuvafem. The 10-mcg estradiol vaginal inserts were shipped to distributors and wholesalers beginning on Oct. 17, 2016.

Yuvafem delivers the same low dose of vaginal estrogen in a pre-loaded, single-use, disposable applicator. It is packaged in 8- and 18-count size quantities for new and maintenance prescriptions.

The product is designed to treat atrophic vaginitis as a result of menopause. The most common adverse effects associated with Yuvafem are upper respiratory tract infection, headache, abdominal pain, back pain, genital pruritus, moniliasis, vulvovaginal mycotic infection, and diarrhea.

Amneal successfully completed a clinical endpoint study required by the FDA prior to Yuvafem’s ANDA approval.

“Patients and healthcare providers have been eager to see a generic for this unique dosage form in order to benefit from the cost savings such multi-source products can deliver,” said Chirag Patel, Amneal co-CEO and chairman, in a press release. “As a company, we are not only pleased to be able to offer a potentially more affordable option in this therapeutic category, but to add to our rapidly growing portfolio of oral contraceptives and hormone replacement therapies in such a significant way.”

The product should not be used in women who have certain conditions, including undiagnosed genital bleeding, known or suspected history of breast cancer, and liver impairment. Some women may also have an increased risk of stroke as a result of using an estrogen-alone therapy.