According to Allergan, the FDA has issued another Complete Response Letter (CRL) in response to Allergan’s NDA for Semprana inhaled dihydroergotamine (formerly Levadex) for the treatment of acute migraine.
Allergan acquired the product when it acquired MAP Pharmaceuticals in early 2013. MAP had already received a CRL for Levadex in early 2012. In April 2013, Allergan announced that the FDA had issued a CRL citing manufacturing problems, including issues with canister filling, and that Allergan had purchased the contract manufacturer, Exemplar.
In its announcement of the most recent CRL, the company says that the “the FDA acknowledged that Allergan has made improvements in the canister filling process” but cited concerns with content uniformity and device actuation specifications.
Allergan now says that it plans to meet with the FDA again and expects the next response from the agency by mid-2015.
Read the Allergan press release.
