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Zogenix, Desitin Pharma get Germany, UK approval for Sumavel DosePro MAA

The Federal Institute for Drugs and Medical Devices of Germany (BrArM) and the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) have approved Zogenix's and Desitin Pharmaceuticals' marketing authorization application (MAA) for Sumavel DosePro (sumatriptan injection) needle-free delivery system.

Sumavel DosePro is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache.

Sumavel DosePro is a pre-filled, single-use disposable, needle-free drug delivery system that subcutaneously delivers 6mg of sumatriptan in 0.5ml of sterile liquid.

Desitin Pharma is planning to introduce Sumavel DosePro in Denmark and Germany in early 2011.