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First, the Company has resubmitted to the FDA its new drug application (NDA) for dihydroergotamine (DHE) prefilled syringe autoinjector for the acute treatment of migraine with or without aura and cluster headache in adults
Following single and repeat doses from 6 to 20 mcg/kg over 6 weeks, gross necropsy revealed no adverse organ changes
However, there is also evidence pointing toward a hepatic origin of circulating DPP-4, and it has been suggested that the inclusion of some patients with unidentified liver disease may have contributed to the conflicting data regarding the association of plasma DPP-4 activity and T2DM
