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OZURDEX INDICATION EXPANDS

Allergan's Levadex headache endures with another CRL

By Michael Fitzhugh
Staff Writer

Monday, June 30, 2014
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Allergan Inc. chalked up a third FDA complete response letter (CRL) regarding Semprana (dihydroergotamine), the orally inhaled acute migraine treatment formerly known as Levadex, and the heart of its $958 million acquisition of MAP Pharmaceuticals Inc. While the company may have existing data to address the manufacturing issues raised in the letter, it estimated the setback will delay further FDA action until the second quarter of 2015.

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