Northern Ireland pharmaceutical group Galen Holdings has won US Federal Drug Administration (FDA) approval to sell its vaginal oestrogen ring.
Galen - which specialises in women's health, skin care and urology - said Femring, a slow-release intravaginal hormone-replacement treatment, would go on sale in the United States in June. It will be used to treat hot flushes and other menopause symptoms.
"As the baby-boomer generation ages and an increasing number of women enter menopause, addressing the symptoms of menopause is a major health concern," Galen Chief Executive Mr Roger Boissonneault said.
He said that with up to 52 million women in the United States expected to be over 50 years or more in the next decade, the product would have a wide market.
Galen has billed Femring as its top product when launched in the key US market, with a potential to make $50 million in sales in three years.
Galen shares closed yesterday at €5.10, valuing the firm at around €939 million.