FDA Declines to Approve Allergan’s LevadexTuesday, April 16, 2013
The Food and Drug Administration cited manufacturing concerns in rejecting Irvine-based Allergan Inc.’s request for approval to market Levadex, a drug to treat acute migraine headaches.
Regulators’ concerns centered on Fall River, Mass.-based Exemplar Pharma LLC, a company that fills canisters for Levadex.
Allergan said in a release that it recently bought Exemplar for about $20 million, and plans to “vigorously address” the concerns the FDA raised. Allergan said that it expects the FDA to reconsider its request on Levadex by the end of 2013.
Allergan got Levadex when it spent $958 million to buy Mountain View-based Map Pharmaceuticals Inc. earlier this year.
Company officials are planning to promote Levadex with its flagship Botox for chronic migraine headaches.
Allergan’s shares were down about 1% to a market value of $33.7 billion in trading today.