Ferring has been notified recently that the mutual recognition process for European member states has been positively concluded for the Zomacton 10mg formulation and the Antares’s needle-free injection device, Zomajet Vision X and consumables.
Following an initial product launch in France, Ferring expects to launch in the other key European markets in 2009. The Zomacton 4mg formulation with the Zomajet 2 Vision needle-free device and consumables was previously approved in Europe and is currently being marketed.
In addition, the Therapeutic Goods Administration, Australia’s regulatory agency for drugs and devices, has recently approved applications filed by Ferring for the Antares Zomajet 2 Vision and Vision X needle-free injection devices, and their associated consumables, to be used with Zomacton in both the 4mg and 10mg formulations.
Paul Wotton, president and CEO of Antares, said: “We are pleased that Ferring continues to expand into new markets and is introducing the Vision X device for use with their Zomacton 10mg product. The combination of the higher strength formulation with Antares’ proprietary needle-free system will continue the focus for both.”