The U.S. Food and Drug Administration or FDA has issued a Complete Response Letter or CRL to Allergan Inc.'s (AGN) New Drug Application or NDA for LEVADEX inhalation aerosol for the acute treatment of migraine in adults.
In addition to the response, the company has already received draft labeling from the FDA. Allergan expects minimal revisions to this labeling, and is committed to bringing LEVADEX to market as a potential new acute treatment to address a significant unmet need among the millions of people living with debilitating migraines.
Per the FDA's comments in the CRL, during a prior inspection, the agency noted concerns with Exemplar Pharma, LLC, the canister filling unit manufacturer. In accordance with its overall manufacturing strategy to secure its supply chain, Allergan concluded the acquisition of Exemplar on April 12, 2013, for less than $20 million. Allergan has named senior members of Allergan's Global Technical Operations to oversee the facility. The multi-specialty health care company anticipates that the FDA would require a re-inspection of the Exemplar facility prior to approval.
Based on Allergan's current understanding of the FDA's CRL, the company expects the next FDA action to occur by the end of fourth-quarter 2013.
Further, Allergan confirmed its prior earnings per share guidance. Even with an FDA approval under the original timeline, 2013 sales of LEVADEX would have been minimal. The company said today's FDA response would not materially impact overall Allergan 2013 sales guidance.
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