The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Allergan's New Drug Application (NDA) for Levadex (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults.
In addition to the CRL, the multi-specialty health care company has already received draft labeling from the FDA and expects minimal revisions to the labeling.
In the CRL, FDA noted concerns with Exemplar Pharma, a canister filling unit manufacturer, and manufacturing process for the final filled canisters.
Allergan said it is committed to address the concerns raised by the FDA in the CRL.
Based on the FDA's CRL, Allergan estimates that the next FDA action will occur by the end of 2013.
As part of its overall manufacturing strategy to secure its own supply chain, Allergan completed the acquisition of Exemplar for less than $20m on 12April 2013.
