Allergan received a complete response letter (CRL) from FDA to its new drug application (NDA) for Levadex (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults, the company said in a press release. The main manufacturing issues cited in the CRL, which were identified by FDA in prior discussions, have already been addressed by Allergan. In addition, Allergan received draft labeling from FDA. The company estimates that the next FDA action will occur by the end of Q4 2013.
In a previous inspection, FDA noted concerns with Exemplar Pharma, the canister filling-unit manufacturer. Allergan subsequently completed the acquisition of Exemplar on April 12, 2013, In accordance with Allergan's overall manufacturing strategy to secure their supply chain. Senior members of Allergan's Global Technical Operations will oversee the facility. Allergan anticipates that FDA will require reinspection of the Exemplar facility prior to approval. FDA also noted concerns regarding the manufacturing process for the final filled canisters, and Allergan has responded to this concern.