FDA Again Rejects Allergan Migraine Drug Levadex

Law360, New York (April 17, 2013, 4:54 PM EDT) -- Allergan Inc. announced Tuesday that the U.S. Food and Drug Administration has again declined to grant regulatory approval for its pending migraine treatment Levadex, citing issues with the manufacture of the drug's inhaler canister.

The FDA had sent a so-called complete response letter to Allergan over its new drug application for Levadex, saying it had concerns over the manufacturing facility of Exemplar Pharma LLC, which makes the canister filling units for the aerosol inhalant drug, the announcement said. The regulator also raised issues with the process...
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