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Amneal set to release Yuvafem

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BRIDGEWATER, N.J. — Amneal Pharmaceuticals LLC next month plans to begin shipping Yuvafem 10-mcg estradiol vaginal inserts, a treatment for menopausal symptoms.

Amneal said Monday that its product represents the first generic equivalent of Vagifem from Novo Nordisk.

amneal-yuvafemYuvafem delivers the same low dose of vaginal estrogen in a preloaded, single-use, disposable applicator. Amneal said the medication is packaged in eight- and 18-count sizes for both initial and maintenance treatment.

Estradiol vaginal tablets are indicated to treat menopausal changes in and around the vagina. Such changes can include vaginal dryness, irritation, itching and soreness, as well as painful urination and pain and bleeding during sex.

“Yuvafem represents a significant addition to our rapidly growing women’s health line,” stated Chirag Patel, co-chief executive officer and chairman at Amneal.  “Our expanding portfolio of oral contraceptives and hormone replacement therapies gives women a broader choice of products to manage their health needs cost-effectively. With Yuvafem, patients and health care providers who prefer this unique dosage-form now have another, more affordable option for treatment.”

U.S. sales of Vagifem totaled $423 million through the 12 months ended in July, according to IMS Health data reported by Amneal.

Yuvafem marks the second women’s health product announced by Amneal this month. The company last week said it has launched the oral contraceptive Femynor, a generic version of Ortho-Cyclen 28.


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