Menu
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)
Related Northern Ireland News Stories
Click here for the latest headlines.
17 August 2017
Manufacturing Firm To Create 57 New Jobs
A manufacturing firm in Northern Ireland has confirmed it is creating almost 60 new jobs as part of expansion plans. Woodland, based in Rasharkin, has invested almost £4 million in a marketing suite and confirmed 57 new posts will be created.
Manufacturing Firm To Create 57 New Jobs
A manufacturing firm in Northern Ireland has confirmed it is creating almost 60 new jobs as part of expansion plans. Woodland, based in Rasharkin, has invested almost £4 million in a marketing suite and confirmed 57 new posts will be created.
11 November 2003
Galen post better than expected full year figures
Northern Ireland based pharmaceuticals company Galen has posted better than expected end of year figures. Total operating profit for the company was up 79% at US$187 million, from almost US$105 million in 2002, and sales revenue rose almost 46% to reach US$432 million in the year, up from US$296 million in 2002.
Galen post better than expected full year figures
Northern Ireland based pharmaceuticals company Galen has posted better than expected end of year figures. Total operating profit for the company was up 79% at US$187 million, from almost US$105 million in 2002, and sales revenue rose almost 46% to reach US$432 million in the year, up from US$296 million in 2002.
25 November 2024
Other News In Brief
DfC Launch Public Consultation On Gender Pay Gap A consultation on proposed changes to Section 19 of the Employment Act (Northern Ireland) relating to the requirements for employers to publish information on the pay of male and female employees has been launched by the Department for Communities.
Other News In Brief
DfC Launch Public Consultation On Gender Pay Gap A consultation on proposed changes to Section 19 of the Employment Act (Northern Ireland) relating to the requirements for employers to publish information on the pay of male and female employees has been launched by the Department for Communities.
14 November 2001
Galen report buoyant trading for year ending 2001
Galen Holdings, the international speciality pharmaceuticals company based in Craigavon, has posted buoyant profit figures. In the last trading year the company reported a turnover of £183 million for the year ended September 2001, up more than double on that of the previous year’s £86 million turnover figure.
Galen report buoyant trading for year ending 2001
Galen Holdings, the international speciality pharmaceuticals company based in Craigavon, has posted buoyant profit figures. In the last trading year the company reported a turnover of £183 million for the year ended September 2001, up more than double on that of the previous year’s £86 million turnover figure.
23 November 2020
Fermanagh Bakery To Create Almost 90 New Jobs
Fermanagh-based bakery, Crust and Crumb, has announced a major investment of £5.8 million and the creation of almost 90 jobs. Crust and Crumb is a leading manufacturer of chilled, frozen and gluten free dough-based products to supermarkets and foodservice customers in Northern Ireland, RoI and GB.
Fermanagh Bakery To Create Almost 90 New Jobs
Fermanagh-based bakery, Crust and Crumb, has announced a major investment of £5.8 million and the creation of almost 90 jobs. Crust and Crumb is a leading manufacturer of chilled, frozen and gluten free dough-based products to supermarkets and foodservice customers in Northern Ireland, RoI and GB.
-
Northern Ireland WeatherToday:A showery start with outbreaks most frequent north of Lough Neagh and through the morning, before dwindling during the afternoon as the northwest breezes ease and brighter spells of weak sunshine prosper. Maximum temperature 8 °C.Tonight:A dry night, save for a few light showers around the coasts, with prolonged clear spells and light winds bringing a frosty dawn for many in central and southern parts. Minimum temperature -3 °C.
