21/10/2002
Galen secures US approval for new menopausal drug
Craigavon-based pharmaceuticals giant Galen Holdings has announced today that it has received approval from the Food and Drug Administration (FDA) in the US for its new 'Menoring' menopause product.
The FDA accepted the 'New Drug Application' for filing in February this year with the product being currently marketed as 'Menoring' in the UK.
Commenting on the announcement, Roger Boissonneault, Galen’s Chief Executive, said: “This approval is a great achievement for the Galen team, both in the US and Northern Ireland. The US is the most significant market for this product and we believe that this innovative form of delivery will be well received by the patient. We look forward to finalising labelling with the FDA and preparing our sales and marketing team for launch.”
The estradiol acetate intra-vaginal ring delivers 50 or 100 micrograms of drug over a 90-day period. The product is administered to women for the treatment of symptoms of menopause.
It will be manufactured by Galen at its Larne facility and will be marketed in the US by Warner Chilcott, a division of Galen.
Galen is an international pharmaceutical company based in Craigavon, Northern Ireland and Rockaway, New Jersey, US.
Galen develops, acquires and manufactures branded prescription pharmaceutical products, which are promoted by the company’s sales and marketing organisations in the UK, Ireland and the US.
(MB)
The FDA accepted the 'New Drug Application' for filing in February this year with the product being currently marketed as 'Menoring' in the UK.
Commenting on the announcement, Roger Boissonneault, Galen’s Chief Executive, said: “This approval is a great achievement for the Galen team, both in the US and Northern Ireland. The US is the most significant market for this product and we believe that this innovative form of delivery will be well received by the patient. We look forward to finalising labelling with the FDA and preparing our sales and marketing team for launch.”
The estradiol acetate intra-vaginal ring delivers 50 or 100 micrograms of drug over a 90-day period. The product is administered to women for the treatment of symptoms of menopause.
It will be manufactured by Galen at its Larne facility and will be marketed in the US by Warner Chilcott, a division of Galen.
Galen is an international pharmaceutical company based in Craigavon, Northern Ireland and Rockaway, New Jersey, US.
Galen develops, acquires and manufactures branded prescription pharmaceutical products, which are promoted by the company’s sales and marketing organisations in the UK, Ireland and the US.
(MB)
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Northern Ireland WeatherToday:A sunny but frosty start for many. However cloud increases by midday with a few showers reaching the north coast, these mostly light but spreading inland this afternoon. Chilly. Maximum temperature 8 °C.Tonight:A rather cloudy evening with scattered showers. Becoming drier through the night with some good clear spells developing and a patchy frost away from coasts. Minimum temperature 0 °C.
