The Food and Drug Administration is concerned about the delivery device for the new acute migraine drug inhalable aerosol formulation of dihydroergotamine, also known as Levadex.
Therefore, it refuses to approve the drug based on its inspection of Exemplar Pharma which is in charge of filling the delivery devices for Allergan. Allergan claims it recently bought the Exemplar firm outright and has sent senior officials to manage the facility, so expects the FDA to do another inspection.
Dihydroergotamine is already available as a nasal spray and for injection or infusion. So if you are a Fibro migraine sufferer, you can use these already available forms if they don’t irritate you and you have access to them.
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