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Complete Response Letter from FDA for Levadex (MAP Pharma) for Migraine

Read time: 1 mins
Last updated:18th Oct 2012
Published:18th Oct 2012
Source: Pharmawand
The FDA has issued a Complete Response Letter to MAP Pharma to its new drug application for Levadex (dihydroergotamine meyslate) inhalation aerosol for the acute treatment of Migraine. The FDA has raised issues on chemistry, manufacturing and controls but has not required a new trial Allergan will co-market Levadex in the USA.

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