The Northern Ireland pharmaceutical group, Galen Holdings, has received an approvable letter for its neworal contraceptive from the US Food and Drug Administration (FDA).
The approvable letter for the company's Ovcon product represents an important step before a product receives FDA approval for marketing the product in the United States.
The items arising from the FDA's letter include confirmation of the resolution of certain issues at the facility where the product is manufactured, and final agreement with the agency on product labelling and expiration dating.
Galen expects that these items will be addressed and a response submitted to the agency as rapidly as possible.
"We are pleased that we have reached this milestone for our new product on schedule. We are committed to expeditiously fulfilling the remaining requirements of the FDA and progressing towards approval," Mr Roger Boissonneault, Galen's CEO said this afternoon
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.