Semprana dihydroergotamine regulatory update

Allergan said FDA issued the third complete response letter for a resubmitted NDA for Semprana dihydroergotamine for the acute treatment of migraines in adults. The company said the 2 specific items listed in the letter are related to specifications around content uniformity on the improved canister filling process and on standards for device actuation. Allergan said there were no issues related to the clinical safety and efficacy of Semprana and that FDA acknowledged Allergan has made improvements in the canister filling process. The company plans to meet with the agency to address the issues in the letter and expects the next FDA action to occur by the end of 2Q15. ...