FDA sends CRL rejecting Allergan's migraine drug Levadex on quality issues

17 April 2013

US drugmaker Allergan (NYSE: AGN) said yesterday (April 16) that the US Food and Drug Administration has issued a Complete Response Letter (CRL) relating o its New Drug Application for Levadex (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults, expressing problems with the manufacturing of the completed canisters for the product.

Allergan said it has already received draft labeling from the FDA Levadex to market as a potential new acute treatment to address a significant unmet need among the millions of people living with debilitating migraines.

The main issues cited in the CRL were already identified by the FDA in prior discussions with Allergan. The company says it has already taken the following actions to address these concerns:

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