Allergan, which recently acquired MAP Pharmaceuticals, has announced that it has received a Complete Response Letter (CRL) from the FDA in regard to its NDA for Levadex inhaled dihydroergotamine for the treatment of migraines. The company also announced that it has acquired CMO Exemplar, which had previously received a form 483 for problems with Levadex manufacturing.
Allergan says that it was already aware of all of the issues identified in the CRL and that it “is pleased that, in addition to the response, the company has already received draft labeling from the FDA”‘ that it “anticipates minimal revisions to this labeling”; and that it remains “committed to bringing Levadex to market.”
In order to address the FDA’s concerns, the company said, it acquired Exemplar for under $20 million and “has appointed senior members of Allergan’s Global Technical Operations to oversee the facility.” Allergan says that it expects a re-inspection of the facility and that the FDA will act by the end of 2013.
In its statement, Allergan said that the CRL would not affect its sales guidance for 2013 since Levadex sales would have been minimal this year even if the product had been approved when expected previously.
Read the Allergan press release.
