New Ovcon 35 receives FDA approval

Published: 2-Dec-2003

Galen Holdings, the specialty pharmaceutical company, has received approval of Ovcon 35 (norethindrone and ethinyl estradiol tablets, chewable)


Galen Holdings, the specialty pharmaceutical company, has received approval of Ovcon 35 (norethindrone and ethinyl estradiol tablets, chewable)

Ovcon 35 chewable tablets are a convenient form of Galen's successful Ovcon 35 oral contraceptive containing 0.4mg norethindrone and 35mcg ethinyl estradiol. The product is marketed in the US by Warner Chilcott, Galen's US subsidiary. The new product gives the option to chew or swallow and has a pleasant flavour. It is designed to enhance both convenience and compliance for patients taking oral contraceptives.

Galen filed a New Drug Application (NDA) for the product on 29 March 2002 and received an Approvable Letter from the Agency on 31 January 2003. This final approval signals that the outstanding issues addressed in that letter have now been resolved to the satisfaction of the Agency.

Commenting on the approval, Roger Boissonneault, ceo of Galen said: 'The approval of this second generation product will enable us to continue to develop our Ovcon franchise, which has grown by almost 30% in the last year. This new product will help to improve patient compliance, while at the same time enhancing convenience.'

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