Needle-free injection device approved in Europe and Australia
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Antares Pharma, Inc. today announced that its license partner, Ferring Pharmaceuticals has received additional regulatory approvals in Europe and Australia for use of Antares’ needle-free injection devices with its human growth hormone (hGH), Zomacton.
Ferring has been notified recently that the mutual recognition process for European member states has been positively concluded for the Zomacton 10 mg formulation and the Antares’ 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 4 mg 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 4 mg and 10 mg formulations.
Paul Wotton, Ph.D., President and Chief Executive Officer of Antares, commented, We are pleased that Ferring continues to expand into new markets and is introducing the Vision X device for use with their Zomacton 10 mg product. The combination of the higher strength formulation with Antares’ proprietary needle-free system will continue the focus for both companies of enhancing patient compliance and convenience with self administration of hGH.
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